cdsco-md-info/device-class.html

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 {
   "MEDICAL DEVICE NAME": "Anesthesia machine",
   "INTENDED USE": "A medical device used to generate and mix a fresh gas flow\nof medical gases and inhalational anaesthetic agents for the\npurpose of inducing,monitoring and maintaining\nanaesthesia.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Aerosol delivery tubing",
   "INTENDED USE": "A flexible tube used in conjunction with an oxygen mask,\nendotracheal (ET) tube, humidifier, or nebulizer, intended\nfor the delivery of aerosolized humidification, typically\noxygen enriched.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Aerosol face mask",
   "INTENDED USE": "A flexible, form-shaped device that is placed over the nose\nand mouth to deliver air, oxygen (O2), or a mixture of the\ntwo gases, with aerosolized particles, to a patient's airway.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Aerosol inhalation monitor",
   "INTENDED USE": "It is a device that enables a medical professional to\nobjectively assess in detail how the test subject uses their\ninhaler.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Airway device cleaning utensil",
   "INTENDED USE": "A hand-held device intended to be used to clean an in situ\nand ex situ airway device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Airway pressure alarm",
   "INTENDED USE": "A device connected to the breathing circuit that monitors a\npatient's upper airway pressure during assisted mechanical\nventilation.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Airway pressure/oxygen monitor",
   "INTENDED USE": "It is a device intended to continuously measure and display\nthe breathing circuit pressure and oxygen (O2)\nconcentration levels of respiratory gases delivered to a\npatient through positive pressure ventilation systems.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Airway protection face mask",
   "INTENDED USE": "A flexible, form-shaped device that is placed over the nose\nand mouth to provide respiratory protection.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Airway temperature monitoring system",
   "INTENDED USE": "An assembly of devices used to continuously measure the\ntemperature at a specific point along a ventilation airway.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Airway tube forceps",
   "INTENDED USE": "A hand-held instrument used for grasping a tube for its\ninsertion and/or extraction into/from the airways, or for\ngrasping obstructive objects for their removal from the\nairways.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Anaesthesia workstation gas\nscavenger",
   "INTENDED USE": "A device intended to connect between the expiratory\nvalve/port of a breathing circuit and the extraction system\nenabling the waste anaesthetic, exhaled, or other trace\ngases to be removed under controlled conditions from the\nwork environment and channelled to the outside of the\nbuilding.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Anaesthetic gas absorption/desorption\ndevice",
   "INTENDED USE": "A device intended to, when integrated within the common\nline of a breathing circuit, absorb and desorb (i.e., recycle)\nexhaled volatile anaesthetic agents.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Anaesthetic gas scavenging terminal\nunit",
   "INTENDED USE": "A device intended to function as an outlet assembly to which\nthe operator can connect/disconnect an anaesthetic gas\nscavenging system (AGSS).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Anesthesia Face Mask",
   "INTENDED USE": "A device designed to be placed over a patient's nose and/or\nmouth to administer anaesthetic gases to the upper airway.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Artificial airway stylet",
   "INTENDED USE": "A device intended for insertion within the lumen of an\nartificial airway tube to stiffen and/or maintain the shape of\nthe tube to facilitate intubation.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Artificial airway washing/disinfection jar",
   "INTENDED USE": "A container intended to hold artificial airway devices to\nfacilitate their washing/disinfection.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Atomizer",
   "INTENDED USE": "A device that is intended to provide liquid medication in\naerosolized form into the air that a patient will breathe.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Brachial plexus anaesthesia kit",
   "INTENDED USE": "A collection of devices intended to deliver a brachial plexus\nnerve block through one of several routes that could include\nsupraclavicular, interscalene, infraclavicular, or axillary.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Breathing circuit bag",
   "INTENDED USE": "A device intended to store breathing gas during the\nrespiratory cycle.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Breathing circuit condenser",
   "INTENDED USE": "A device intended to be integrated within the expiratory limb\nof a breathing circuit to remove excess moisture through\ncooling and condensing, whilst also reheating the dried\ngases to an appropriate machine-compatible temperature.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Breathing circuit dryer",
   "INTENDED USE": "A device that is used for the purpose of drying breathing\ncircuit equipment that have been washed inorder to prevent\nbacteria growth and deterioration",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Carbon dioxide monitor",
   "INTENDED USE": "A device intended to continuously measure the\nconcentration of carbon dioxide (CO2) in a gas mixture to\ndetermine a patient's ventilatory, circulatory, or metabolic\nstatus.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "CPAP/BPAP nasal mask",
   "INTENDED USE": "A device designed to be placed over a user's nose to\ninterface with a continuous positive airway pressure (CPAP)\nor bi-level positive airway pressure (BPAP) unit to provide\nthe respiratory tract with direct ambient air, or medical\noxygen (O2) and air, at a higher pressure than ambient air\nfor noninvasive positive pressure ventilation (NPPV).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "CPAP/BPAP oral mask",
   "INTENDED USE": "A device designed to be fitted to the user's mouth to\ninterface with a continuous positive airway pressure (CPAP)\nor bi-level positive airway pressure (BPAP) unit to provide\nthe respiratory tract with direct ambient air, or medical\noxygen (O2) and air, at a higher pressure than ambient air\nfor noninvasive positive pressure ventilation (NPPV).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Electronic epidural space locator\ncontrol unit",
   "INTENDED USE": "A device intended to be used with an epidural needle and\nan electronic epidural space locator pressure-sensing set, to\naid a user in locating the epidural needle tip within the\nepidural space for subsequent anaesthesia administration.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Electronic oesophageal stethoscope",
   "INTENDED USE": "An electronic listening device designed to be inserted into a\npatient's oesophagus to listen to heart and breathe sounds,\ntypically while the patient is under anaesthesia.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Endobronchial airway sizing kit",
   "INTENDED USE": "A collection of mechanical devices intended to be used with\na balloon catheter for a planned intervention to determine\nthe appropriate endobronchial valve sizes for a patient's\nlung airways (bronchial lumens).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Endobronchial tube",
   "INTENDED USE": "A hollow cylinder that is designed for oral insertion via the\ntrachea and into a lung to maintain airway patency and/or to\ndeliver anaesthetic inhalation agents or other medical\ngases, and secure ventilation.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Intravascular membrane oxygenator",
   "INTENDED USE": "A device designed for intravascular diffusion of oxygen into\nand carbon dioxide from the blood across an implantable\n(vena cava) gas-permeable membrane, used mainly as a\ntemporary treatment for failing lungs in adults with\nrespiratory distress syndrome.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Intravascular oximeter",
   "INTENDED USE": "An instrument designed for the continuous in vivo\nmeasurement of venous blood oxygen saturation (SvO2)\nusing a fibreoptic catheter.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Intubation laryngoscope",
   "INTENDED USE": "A hand-held device intended to be used by\nanaesthesia/emergency service personnel to manipulate the\ntongue, preventing it from obstructing the oropharynx and\nenabling a clear view of the trachea for the insertion of an\nendotracheal (ET) tube prior to the delivery of inhalation\nanaesthesia and/or ventilation.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Intubation teeth protector",
   "INTENDED USE": "A device designed to fit over the upper and lower sets of\nteeth to protect them from damage during endotracheal\n(ET) tube intubation procedures.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Invasive arterial pressure cardiac\noutput/oximetry monitor",
   "INTENDED USE": "A device intended to continuously measure and display\narterial pressure cardiac output (APCO) and haemoglobin\noxygen saturation (e.g., SpO2) when connected to an\nextravascular blood pressure transducer linked to a\nperipheral arterial line, and to a pulse oximeter or an\noximetry catheter.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Laryngeal airway",
   "INTENDED USE": "A curved tube used in inhalational anaesthesia and\nresuscitation to facilitate and secure airway patency for the\ndelivery and exchange of gases in spontaneously breathing\nand ventilated patients.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Laryngeal airway introducer",
   "INTENDED USE": "A device intended to aid insertion of a laryngeal airway into\nthe pharyngeal cavity of a patient while reducing or\neliminating the need for finger manipulation within the\nmouth. It is typically in the form of a metal blade with a\nhandle and may be mounted onto the laryngeal airway\nduring insertion. This is a reusable device intended to be\nsterilized prior to use.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Medical gas terminal unit",
   "INTENDED USE": "A device that is a component of a medical gas pipeline\nsystem or a medical gas/vacuum pipeline system that has a\ngas-specific outlet connection for a single/mixture of gas to\nwhich the operator can connect and disconnect a medica\ndevice.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Medicine chamber spacer",
   "INTENDED USE": "A device intended to be placed between a nebulizer or a\nmetered dose inhaler (MDI) and the patient's mouth, to\nfunction as a reservoir into which an aerosol medication is\ndispensed in order to minimize delivery of large aerosolized\nparticles.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Microbial medical gas filter",
   "INTENDED USE": "A screening device intended to remove microbes from\nmedical gases to prevent patient exposure during\nrespiration, anaesthesia and/or endoscopy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Nasopharyngeal airway",
   "INTENDED USE": "A rubber or plastic tube that extends into the pharynx from\neither naris to maintain airway patency.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Negative-pressure ventilator",
   "INTENDED USE": "An automatic cycling machine used to assist or control\nalveolar respiration that exerts a negative pressure on the\nexternal surface of the chest wall, expanding the chest and\nmoving air into the lungs.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Neonatal chest percussor",
   "INTENDED USE": "A hand-held device (a percussor) intended to be operated\nby a healthcare professional to provide external vibrations to\nthe chest wall of a neonate to help loosen bronchial mucus\nfor expectoration through suctioning. It is used to help\nloosen secretion build-up in the lungs of neonates who\ncannot perform the natural cough mechanism.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Nerve-block injection manometer",
   "INTENDED USE": "A noninvasive device intended to be connected between a\nsyringe and a nerve-block needle to indicate injection\npressure during administration of local or regional\nanaesthesia to achieve peripheral nerve blockade.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Nitric oxide delivery unit",
   "INTENDED USE": "A device intended for the delivery of precise amounts of\nnitric oxide (NO), also known as nitrogen monoxide, to the\nrespiratory tract of neonate, paediatric, and adult patients to\ntreat severe respiratory disorders.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Peak flow meter",
   "INTENDED USE": "A device designed to measure the maximum rate of\nexpiratory gas flow [peak expiratory flow (PEF) or peak\nexpiratory flow rate (PEFR)] and forced expiratory volume\n(FEV) from the lungs. The device is typically intended to\nmonitor the respiratory status of a patient suffering from\nchronic respiratory disease in a clinical setting or the home.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pleural manometer",
   "INTENDED USE": "A noninvasive device intended to convert pressure into\nelectrical signals for the measurement of pressure within the\npleural cavity.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pneumatic chest percussor",
   "INTENDED USE": "A hand-held pneumatic device designed to provide external\nvibrations to the chest wall of a patient to loosen excessive\nairway secretions to promote airway clearance and improve\nbronchial drainage for patients with respiratory disease.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pressure algometer/aesthesiometer",
   "INTENDED USE": "An instrument designed to measure a patient's sensitivity to\npain (pain threshold) and tactile sensibility.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pulmonary function analysis system",
   "INTENDED USE": "A device used to measure the function of the respiratory\nsystem in adults and compliant children.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pulmonary resuscitator",
   "INTENDED USE": "A hand-operated device designed to provide or assist\nventilation in patients who are apnoeic or exhibit inadequate\nrespiration.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Pulse Co-oximeter",
   "INTENDED USE": "A device designed to detect hypoxia via the transcutaneous\nmultiwave measurement and display of carboxy-\nhaemoglobin saturation (SpCO) and typically other related\nparameters such as haemoglobin oxygen saturation\n(SpO2), methaemoglobin saturation (SpMet), and\nhaemoglobin concentration (SpHb).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pulse oximeter",
   "INTENDED USE": "A device intended for the transcutaneous measurement and\ndisplay of haemoglobin oxygen saturation (SpO2).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Rebreathing oxygen face mask",
   "INTENDED USE": "A flexible, form-shaped device designed to be placed over\nthe nose and mouth to deliver a proportional mixture of\nair/oxygen (O2) to a patient's airway.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Tracheal surgery dilator",
   "INTENDED USE": "A hand-held manual surgical instrument intended to be used\nduring surgical intervention of the trachea to dilate tracheal\nstructures/passages, typically during the creation of a\ntracheostoma and/or for expanding the margins of a\ntracheostoma to assist in the insertion of a tracheostomy\ntube.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Tracheostomy kit",
   "INTENDED USE": "A collection of surgical instruments, dilators, tracheostomy\ntubes and other items intended to be used to create a\npercutaneous opening in the trachea (tracheotomy) for the\ninsertion of a tracheostomy tube to relieve upper airway\nobstruction and to facilitate ventilation.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Tracheostomy tube cannula",
   "INTENDED USE": "A hollow, cylindrical, curved device designed as an internal,\nindependent component of a metal tracheostomy tube. It is\nremoved once or more times daily to facilitate the removal\nof phlegm, slime, and contamination build-up, thereby\npreventing blockage and infection of the stoma and\neliminates the traumatic removal of the tracheostomy tube.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Tracheotome",
   "INTENDED USE": "A surgical instrument designed to cut an opening into the\ntrachea (windpipe) through the anterior surface of the neck\nto create an artificial airway (tracheotomy).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ultrasonic cough stimulation system",
   "INTENDED USE": "An assembly of devices designed to stimulate a reflex\ncough using ultrasound in a patient who cannot cough on\ncommand, typically respiratory patients with cortical\ninsufficiency or the very young/elderly, to help clear the\nlungs of secretions and aspirated materials.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ultrasonic respiratory humidifier",
   "INTENDED USE": "A device designed to agitate water into micro-particles with\nultrasound to add moisture to the flow of air/gases\nadministered to a patient via a breathing tube/circuit.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Vacuum-assisted airway secretion-\nclearing system",
   "INTENDED USE": "A device assembly designed to remove excessive secretion\nfrom the lungs and upper airway of patients with respiratory\ndisease or during cardiac rehabilitation through vacuum\ntechnology.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Acupressure calf band",
   "INTENDED USE": "A device designed to be worn around the calf to apply\npressure to an acupressure point to relieve low back pain,\nincluding sciatica and piriformis syndrome.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Acupressure wristband",
   "INTENDED USE": "A device designed to be worn on the wrist(s) for the\napplication of pressure to the Nei-kuan (P6) acupressure\npoint, the area identified to help relieve the sensation of\nnausea.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Acupuncture electrical\nstimulation system",
   "INTENDED USE": "An assembly of devices used to apply electrical stimuli to\nacupuncture sites.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Acupuncture kit",
   "INTENDED USE": "A collection of instruments and supplies used to perform\nacupuncture procedures.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Acupuncture point detector",
   "INTENDED USE": "An electronic probe used to precisely locate an acupuncture\npoint on a patient's body.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Analgesic PENS system",
   "INTENDED USE": "An assembly of devices intended for the relief of chronic\nneuropathic pain through percutaneous electrical nerve\nstimulation (PENS).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Analgesic peripheral nerve\nelectrical stimulation system",
   "INTENDED USE": "An assembly of devices designed to stimulate electrically a\nperipheral nerve in a patient to relieve severe intractable pain.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Analgesic spinal cord\nelectrical stimulation system",
   "INTENDED USE": "An assembly of devices that applies an electrical stimulus to\nall or part of the spinal cord to relieve pain (analgesia).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Analgesic TENS system",
   "INTENDED USE": "An assembly of devices used to reduce the perception of pain\nby electrically stimulating peripheral nerves across the skin\n(transcutaneously).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Arthritis TENS system",
   "INTENDED USE": "An assembly of devices intended to be used as adjunctive\ntherapy in reducing the level of pain and stiffness associated\nwith rheumatoid arthritis or osteoarthritis by electrically\nstimulating peripheral nerves across the skin\n(transcutaneously).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Deep-tissue electromagnetic\nstimulation system",
   "INTENDED USE": "An assembly of devices designed to apply an electromagnetic\n(EM) field to body tissues to: 1) treat musculoskeletal\ndisorders; 2) treat body pain; and/or 3) help facilitate soft and\nhard tissue wound/injury healing, with no production of a\ntherapeutic deep heat.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ear microsystem needle",
   "INTENDED USE": "An instrument used in auriculotherapy to apply continuous\npressure to stimulate meridian points.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Electric pad localized-body\nheating system",
   "INTENDED USE": "An assembly of devices designed for the transcutaneous\napplication of heat to a localized body site to relieve\nmusculoskeletal pain.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Electromechanical\northopaedic extracorporeal\nshock wave/pneumatic\npressure wave therapy\nsystem",
   "INTENDED USE": "An assembly of devices designed to provide\nelectromechanical orthopaedic extracorporeal shock wave\ntherapy (OEST) and pneumatic pressure wave therapy to treat\nmusculoskeletal disorders.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Endothermic cold therapy\npack",
   "INTENDED USE": "A device intended to be applied with pressure to the body\nsurface to provide cold therapy to help reduce fever, pain, and\ninflammation associated with joint/muscle/tissue injury and/or\nminor burns.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Epidural anaesthesia kit",
   "INTENDED USE": "A collection of devices intended to be used to deliver an\nanalgesic or anaesthetic agent to the epidural space for pain\nmanagement.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Epidural/intrathecal\nanaesthesia kit",
   "INTENDED USE": "A collection of devices designed to deliver an analgesic or\nanaesthetic agent into the epidural and subarachnoid\n(intrathecal) spaces around the spinal cord for pain\nmanagement.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Exothermic heat therapy\npack",
   "INTENDED USE": "A device intended to be applied to the body surface,\nsometimes with pressure, to provide heat therapy to reduce\nmuscle spasms and cramps and/or for joint and muscle\nstiffness and pain.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Inflatable hot/cold therapy\npack/electric pump",
   "INTENDED USE": "A assembly of devices intended for localized thermal and\ncompression therapy to facilitate the treatment of a variety of\nadverse conditions resulting from musculoskeletal injury.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Inhalational analgesia unit",
   "INTENDED USE": "A device primarily designed to administer analgesic gases to\nthe patient, or produce analgesic vapours for inhalation.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Interferential electrical\nstimulation system",
   "INTENDED USE": "An device assembly designed to stimulate peripheral nerves\nthrough the transcutaneous application of two currents of\nslightly different frequencies that cross-over/interfere,\nproducing a beating frequency at the treatment point.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Intervertebral disc prolapse\ntherapy pack",
   "INTENDED USE": "A device intended to be applied to the skin overlying an\naffected area of the spine (cervical or lumbar) to reduce pain\nassociated with a prolapsed (herniated) intervertebral disc.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Intubation teeth protector",
   "INTENDED USE": "A device designed to fit over the upper and lower sets of teeth\nto protect them from damage during endotracheal (ET) tube\nintubation procedures.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Inversion table",
   "INTENDED USE": "A fixed framework with a tilting table platform designed to\nsupport the body of a patient and provide traction for the back\nmuscles and spine by allowing the patient manually invert their\nentire body in a supine position (feet up and head down),\nthereby assist patients eliminate/alleviate back pain.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Massage table/couch",
   "INTENDED USE": "A table designed for various kinds of complementary therapy.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Medium-wave diathermy\ntreatment system",
   "INTENDED USE": "An assembly of devices designed to produce a therapeutic\ndeep heat within specific volumes of the body through the\ntranscutaneous transmission of electromagnetic (EM) energy\nin the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1\nMHz. ,to treat pain, muscle spasms, and joint contractures; it\nis not used for surgery or to treat malignancies.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Microwave diathermy\ntreatment system",
   "INTENDED USE": "An assembly of devices designed to produce a therapeutic\nheat below the skin within specific volumes of the body\nthrough the transcutaneous transmission of high frequency\nelectromagnetic (EM) energy, to promote tissue healing and\npain relief.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Pain-relief static magnet",
   "INTENDED USE": "A magnetized metal device designed to be worn on any part of\nthe body (non-dedicated) and intended to produce a weak\nmagnetic flux field over a superficial body site to provide\ncomfort and localized temporary relief of body aches and\npains.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Physical therapy paraffin\nwax bath",
   "INTENDED USE": "A tub/enclosure, with an internal heating assembly, filled with\nliquid paraffin wax for physical therapy, to relieve pain and\nstiffness caused by arthritis or other joint inflammation, muscle\nspasms, or to help stimulate circulation.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Short-wave diathermy\ntreatment system",
   "INTENDED USE": "An assembly of devices designed to provide a therapeutic\ndeep heat within specific volumes of the body through the\ntranscutaneous transmission of electromagnetic (EM) energy\nin the radio-frequency (RF) bands. The device is intended to\ntreat pain, muscle spasms, and joint contractures; it is not\nused for surgery or to treat malignancies.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Sitz bath",
   "INTENDED USE": "A tub filled with water, that is heated by its heating elements\nand circulated by its agitators, intended for use in external\nhydrotherapy to relieve pain or pruritus and to accelerate the\nhealing of inflamed or traumatized tissues of the perianal and\nperineal areas.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Sitz bath chair",
   "INTENDED USE": "A device designed to be sat upon by a patient in a powered\nsitz bath for external hydrotherapy to relieve pain or pruritus\nand to accelerate the healing of inflamed or traumatized\ntissues of the perianal and perineal areas.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Static magnetic back/spine\ninsulator",
   "INTENDED USE": "A pad made of textile fabrics containing magnetic inserts and\ndesigned to be placed on the surface of the skin. on the back\nand/or part or the whole of the spine to help relieve medical\nailme andnts such as pain, muscle tension, poor blood\ncirculation and to provide comfort by improving overall\nmobility.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Static magnetic joint\ninsulator",
   "INTENDED USE": "A pad made of textile fabrics containing magnetic inserts and\ndesigned to be placed on the surface of the skin over/around\na patient's hip or other limb joint to help relieve medical\nailments such as pain, muscle tension, poor blood circulation\nand to provide comfort by improving overall mobility.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Static magnetic knee\northosis",
   "INTENDED USE": "A body-support device containing or impregnated with\nmagnetized metals or metallic compounds, designed to be\nworn around the knee joint to support the knee and produce a\nweak magnetic flux field that emanates from the surface of the\nknee to assist the whole body<64>s innate healing capability to\nalleviate body aches and pains.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Static magnetic lumbar\nspine orthosis",
   "INTENDED USE": "A body-support device containing or impregnated with\nmagnetized metals or metallic compounds, designed to be\nworn around the hips to support the lower back (spine and\ncoccyx) and produce a weak magnetic flux field that emanates\nfrom the surface of the lower back to assist the whole body<64>s\ninnate healing capability to alleviate body aches and pains.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Static magnetic massager",
   "INTENDED USE": "A device designed to be moved over body surfaces that uses\nstatic magnets intended to produce a weak magnetic flux over\na superficial body site to provide comfort and localized\ntemporary relief from minor aches and pains.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Static magnetic shoulder\northosis",
   "INTENDED USE": "A body-support device containing or impregnated with\nmagnetized metals or metallic compounds, designed to be\nworn around the shoulder joint to support the shoulder and\nproduce a weak magnetic flux field that emanates from the\nsurface of the shoulder to assist the whole body<64>s innate\nhealing capability to alleviate body aches and pains.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Arrhythmia Detector And\nAlarm (Including St-\nSegment Measurement\nAnd Alarm).",
   "INTENDED USE": "The arrhythmia detector and\nalarm device monitors an\nelectrocardiogram and is\ndesigned to produce a visible or\naudible signal or alarm when\natrial or ventricular arrhythmia,\nsuch as premature contraction or\nventricular fibrillation, occurs.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiac monitor (including\ncardiotachometer and rate\nalarm)",
   "INTENDED USE": "A cardiac monitor (including\ncardiotachometer and rate alarm)\nis a device used to measure the\nheart rate from an analog signal\nproduced by an\nelectrocardiograph,\nvectorcardiograph, or blood\npressure monitor. This device\nmay sound an alarm when the\nheart rate falls outside preset\nupper and lower limits.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Electrocardiograph.",
   "INTENDED USE": "An electrocardiograph is a device\nused to process the electrical\nsignal transmitted through two or\nmore electrocardiograph\nelectrodes and to produce a\nvisual display of the electrical\nsignal produced by the heart.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Electrocardiograph\nelectrode.",
   "INTENDED USE": "An electrocardiograph electrode\nis the electrical conductor which\nis applied to the surface of the\nbody to transmit the electrical\nsignal at the body surface to a\nprocessor that produces an\nelectrocardiogram or\nvectorcardiogram.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Vascular clip",
   "INTENDED USE": "A vascular clip is an implanted\nextravascular device designed to\nocclude, by compression, blood\nflow in small blood vessels other\nthan intracranial vessels.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ventricular bypass (assist)\ndevice.",
   "INTENDED USE": "A ventricular bypass (assist)\ndevice is a device that assists the\nleft or right ventricle in\nmaintaining circulatory blood flow.\nThe device is either totally or\npartially implanted in the body.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Pacemaker generator\nfunction analyzer.",
   "INTENDED USE": "A pacemaker generator function\nanalyzer is a device that is\nconnected to a pacemaker pulse\ngenerator to test any or all of the\ngenerator's parameters, including\npulse duration, pulse amplitude,\npulse rate, and sensing threshold.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiovascular permanent\nor temporary pacemaker\nelectrode.",
   "INTENDED USE": "Identification. A temporary\npacemaker electrode is a device\nconsisting of flexible insulated\nelectrical conductors with one end\nconnected to\nan external pacemaker pulse\ngenerator and the other end\napplied to the heart. The device is\nused to transmit a pacing\nelectrical stimulus from the pulse\ngenerator to the heart and/or to\ntransmit the electrical signal of\nthe heart to the pulse generator.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pacemaker electrode\nfunction tester.",
   "INTENDED USE": "A pacemaker electrode function\ntester is a device which is\nconnected to an implanted\npacemaker lead that supplies an\naccurately calibrated, variable\npacing pulse for measuring the\npatient's pacing threshold and\nintracardiac R-wave potential.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pacemaker service tools.",
   "INTENDED USE": "Pacemaker service tools are\ndevices such as screwdrivers and\nAllen wrenches, used to repair a\npacemaker lead or to reconnect a\npacemaker lead to a pacemaker\ngenerator.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Annuloplasty ring.",
   "INTENDED USE": "An annuloplasty ring is a rigid or\nflexible ring implanted around the\nmitral or tricuspid heart valve for\nreconstructive treatment of\nvalvular insufficiency.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiopulmonary bypass\nheart-lung machine\nconsole.",
   "INTENDED USE": "A cardiopulmonary bypass heart-\nlung machine console is a device\nthat consists of a control panel\nand the electrical power and\ncontrol circuitry for a heart-lung\nmachine. The console is\ndesigned to interface with the\nbasic units used in a gas\nexchange system, including the\npumps, oxygenator, and heat\nexchanger.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiopulmonary bypass\ndefoamer.",
   "INTENDED USE": "A cardiopulmonary bypass\ndefoamer is a device used in\nconjunction with an oxygenator\nduring cardiopulmonary bypass\nsurgery to remove gas bubbles\nfrom the blood.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiopulmonary bypass\nheat exchanger.",
   "INTENDED USE": "A cardiopulmonary bypass heat\nexchanger is a device, consisting\nof a heat exchange system used\nin extracorporeal circulation to\nwarm or cool the blood or\nperfusion fluid flowing through the\ndevice.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiopulmonary bypass\ncardiotomy suction line\nblood",
   "INTENDED USE": "A cardiopulmonary bypass\ncardiotomy suction line blood filter\nis a device used as part of a gas\nexchange (oxygenator) system to\nfilter nonbiologic particles and\nemboli (a blood clot or a piece of\nforeign material flowing in the\nbloodstream which will obstruct\ncirculation by blocking a vessel)\nout of the blood. This device is\nintended for use in the cardiotomy\nsuction line.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiopulmonary bypass\npulsatile flow generator.",
   "INTENDED USE": "A cardiopulmonary bypass\npulsatile flow generator is an\nelectrically and pneumatically\noperated device used to create\npulsatile blood flow. The device is\nplaced in a cardiopulmonary\nbypass circuit downstream from\nthe oxygenator.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "External transcutaneous\ncardiac pacemaker",
   "INTENDED USE": "An external transcutaneous\ncardiac pacemaker (noninvasive)\nis a device used to supply a\nperiodic electrical pulse intended\nto pace the heart. The pulse from\nthe device is usually applied to\nthe surface of the chest through\nelectrodes such as defibrillator\npaddles.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Dental crown/bridge\nresin, temporary",
   "INTENDED USE": "A material used to manufacture crowns and bridges.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Dental\ncrown/bridge,\ntemporary",
   "INTENDED USE": "Intended to make a temporary crown or bridge prosthesis for\nuse until a permanent restoration is fabricated.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Dental material\nmixing surface,\nreusable",
   "INTENDED USE": "A dental instrument slab or tray used as a surface to mix dental\nmaterials.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental material\nmixing surface,\nsingle-use",
   "INTENDED USE": "It has pad or tray used to knead or mix dental material\n(impression material, cement, etc).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental spatula,\nreusable",
   "INTENDED USE": "A dental instrument used to mix dental materials. Some are\nequipped with an injection function.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental spatula,\nsingle-use",
   "INTENDED USE": "A spatula-shaped device used to knead or mix dental material\n(impression material, cement, etc).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental impression\nmaterial kit, single-\nuse",
   "INTENDED USE": "A collection of non-sterile devices designed to obtain a negative\nimprint of the teeth. The kit typically includes dental impression\nmaterials and a dental impression tray(s); This is a single-use\ndevice.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental impression\nmaterial mixer",
   "INTENDED USE": "An electric device used to mix impression materials immediately\nbefore use at the chair side.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental impression\nmaterial syringe",
   "INTENDED USE": "This dental injection syringe is used to inject the impression\nmaterial onto the impression tray.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental impression\ntray material",
   "INTENDED USE": "A material intended to be used to create a custom impression\ntray intended for filling with dental impression materials; it is not\nintended for the fabrication of a patient-worn dental appliance.\nThe material is used in cases in which a preformed impression\ntray is not suitable.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental impression\ntray, reusable",
   "INTENDED USE": "A impression tray is a metal or plastic device intended to hold\nimpression material, to make an impression of a patient's teeth\nto reproduce the structure of a patient's teeth.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental suction\nsystem cannula,\nreusable",
   "INTENDED USE": "A tubal dental device to be connected to a non-active aspiration\ndevice (usually, a dentistry dedicated device). Used to eliminate\nwater and cutting debris that have accumulated in the oral\ncavity. This device is reusable after sterilization.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental suction\nsystem cannula,\nsingle-use",
   "INTENDED USE": "A tubal dental device to be connected to a non-active aspiration\ndevice (usually, a dentistry dedicated device). Used to eliminate\nwater and cutting debris that have accumulated in the oral\ncavity.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Carboxymethylcellul\nose sodium denture\nadhesive",
   "INTENDED USE": "An adhesive compound composed of carboxymethylcellulose\nsodium (usually 40 to 100%) used to stabilize a removable\nprosthesis in the mouth, particularly a denture, by adhering the\nprosthesis to the oral mucosa. The compound is typically\napplied to the base of a denture before it is inserted in the\nmouth.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Dental suction\nsystem pump",
   "INTENDED USE": "An electrically-powered dental suction pump used as the\nsuction source of a dental suction system, dental treatment unit,\netc.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Plaster dental\nimpression material",
   "INTENDED USE": "This material is primarily made of calcium sulphate\nhemihydrate, and used to take an oral impression.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Polyether dental\nimpression material",
   "INTENDED USE": "An elastic material primarily made of polyether, which forms a\nrubber-like material suitable for taking impressions after\nreaction.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Polysulfide dental\nimpression material",
   "INTENDED USE": "An elastic material primarily made of polysulfide, which forms a\nrubber-like material suitable for taking impressions after\nreaction.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Silicone dental\nimpression material",
   "INTENDED USE": "An elastic material primarily made of polysiloxane, which forms\na rubber-like material suitable for taking impression after\nreaction.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Basic electric\ntoothbrush, battery-\npowered",
   "INTENDED USE": "A rotary dental brush used for cleaning teeth and gum by a\nperson or a dental hygienist.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental suction\nsystem disinfection\ncontrol unit",
   "INTENDED USE": "An electrically-powered device intended to control the regular\n(typically daily) automated/semi-automated disinfection of a\ndental suction system tubing line.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Transgingival\nimplant",
   "INTENDED USE": "A sterile device intended to be surgically implanted through the\noral mucosa and gingiva to provide support and a means of\nretention for a dental prosthesis.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Zinc\npolycarboxylate\ndental cement",
   "INTENDED USE": "A non-sterile substance intended for professional use as a\ndental cement (e.g., luting agent, liner, base) and/or direct\ndental restorative material whereby the majority of the setting\nreaction is based on the hardening reaction between zinc oxide\n(ZnO) and aqueous solutions of polycarboxylic acid (e.g.,\npolyacrylic acid).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Periodontal root\nsurface\nregeneration\nmaterial",
   "INTENDED USE": "A bioabsorbable material intended to be used alone or in\ncombination with bone graft materials for the regeneration of\ntooth support that has been lost due to periodontal disease or\ntrauma. It is applied during periodontal flap surgery to the\nscaled and preconditioned root surface and forms an insoluble\nmatrix that creates a suitable root surface for selective\nperiodontal cell migration and cell attachment, which re-\nestablishes the lost tooth support.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Periodontal tissue\nreconstructive\nmaterial",
   "INTENDED USE": "A sterile viscous material intended to be injected into the buccal\nmucosa to treat deficiencies of the gingiva (e.g., interdental\npapillae), through augmentation, during the treatment of\nintermediate stage periodontal disease.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Bone matrix\nimplant, human-\nderived",
   "INTENDED USE": "A sterile implantable device made primarily of human\ndemineralized bone matrix (DBM) intended to fill bony voids or\ngaps caused by trauma or surgery, including use in the\nmaxillofacial and/or mandibular bone.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Preformed dental\ncrown, temporary",
   "INTENDED USE": "This device is commonly used during prosthodontic treatment\nor other restorative work required as a result of traumatic injury.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Zinc phosphate\ndental cement",
   "INTENDED USE": "A non-sterile substance intended for professional use as a\ndental cement and/or direct dental restorative material whereby\nthe majority of the setting reaction is based on the hardening\nreaction between an oxide powder [the principal constituent of\nwhich is zinc oxide (ZnO)] and an aqueous solution of\nphosphoric acid.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Dental articulation\npaper forceps",
   "INTENDED USE": "A hand-held manual dental instrument designed for grasping\nand holding articulation paper during its application to a\npatient's oral cavity.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental dressing\nforceps, reusable",
   "INTENDED USE": "A hand-held manual dental instrument designed for grasping\nand holding a dental dressing during its application to a\npatient's oral cavity.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental anaesthesia\nsyringe cartridge",
   "INTENDED USE": "A plastic or glass container prefilled with a single dose of\nanaesthetic medication intended to be inserted into a dental\nanaesthesia syringe and injected into oral tissues for a dental\nprocedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Dental anaesthesia\nsyringe,\nintraligamentary",
   "INTENDED USE": "A hand-held manual dental instrument intended to be used to\ninject an anaesthetic agent under pressure via the periodontal\nligament or into bone through an attached sterile needle. This is\na reusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental anaesthesia\nsyringe, reusable",
   "INTENDED USE": "A hand-held manual dental instrument intended to be used for\ninjecting an anaesthetic agent, subcutaneously or\nintramuscularly, from a prefilled, single-use cartridge through an\nattached sterile needle; a needle is not included.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental anaesthesia\nsyringe, single-use",
   "INTENDED USE": "A sterile, hand-held, manual dental instrument intended to be\nused for injecting an anaesthetic agent, subcutaneously or\nintramuscularly, from a prefilled, single-use cartridge through an\nattached sterile needle (needle not included).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dental anaesthesia\nsyringe/needle",
   "INTENDED USE": "A hand-held manual dental instrument intended to be used for\ninjecting an anaesthetic agent, subcutaneously or\nintramuscularly, from a prefilled, single-use cartridge through an\nincluded sterile needle; the needle may be attached or\ndetached.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Bite registration rim\nwax, plate",
   "INTENDED USE": "A dental material (modelling wax) delivered as prefabricated\nplates of wax with or without reinforcing foils (metal, polymer)\nfor registration of jaw relation (making bite rims).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Calcium hydroxide\ndental cement",
   "INTENDED USE": "use as a dental cement and/or direct dental restorative material\nwhereby the majority of the setting reaction is based on the\nhardening reaction between calcium hydroxide and salicylic\nacid .",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Adenotome",
   "INTENDED USE": "Surgical instrument intended to dissect the adenoids.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Adenotome blade",
   "INTENDED USE": "Intended to mount on adenotome and perform dissection of adenoids.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Anchored bone-conduction\nhearing implant system",
   "INTENDED USE": "Intended to treat hearing impairment due to middle and/or outer ear obstructive pathologies or types\nof conductive hearing loss.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Audiometer testing system",
   "INTENDED USE": "An assembly of electronic reference devices intended to calibrate an audiometer.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Audiometer",
   "INTENDED USE": "Intended for evaluation of hearing by generating tones throughout the audible range",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Otoscope",
   "INTENDED USE": "Intended for visual examination of the outer ear canal and tympanic membrane (eardrum) by direct\nviewing through the ear opening.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Auditory evoked-potential\ngraphic recorder",
   "INTENDED USE": "Intended to record an electrical potential that originates in the auditory pathway of the brain in\nresponse to acoustic stimuli.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Auditory stimulator",
   "INTENDED USE": "Intended to apply sound stimuli to a patient's acoustic system.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Behind-the-ear air-conduction\nhearing aid",
   "INTENDED USE": "Intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum\nthrough air.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Behind-the-ear air-conduction\ntinnitus masker",
   "INTENDED USE": "Intended to provide noise of sufficient intensity and bandwidth to mask tinnitus.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Behind-the-ear bone-\nconduction tinnitus masker",
   "INTENDED USE": "Intended to provide ultrasonic broadband noise and/or sweep-frequency stimuli noise of sufficient\nintensity and bandwidth to mask tinnitus.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cochlear implant assessment\nsystem",
   "INTENDED USE": "Intended to perform an integrity test on the implantable portion of a cochlear implant (CI) system in-\nsitu.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Ear bowl",
   "INTENDED USE": "Constructed to fit the curvature of the head so that it will sit closely under the ear lobe and enable\ntreatments of ear.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ear canal impression tray",
   "INTENDED USE": "Intended to hold and confine the impression material in opposition to the surfaces to be recorded,\nand to control the impression material while it sets to form the impression of the ear canal.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ear canal light",
   "INTENDED USE": "Intended to illuminate the ear canal.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ear excavator",
   "INTENDED USE": "Designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or\naround the ear.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ear prosthesis",
   "INTENDED USE": "Intended to reconstruct the external ear by replacing damaged or missing tissue.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Ear wick",
   "INTENDED USE": "Intended to mimimize bleeding during ear surgery.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "ENT Nasal snare",
   "INTENDED USE": "A hand-held manual surgical instrument intended to be inserted into the naris for the removal of\ntissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during\near/nose/throat (ENT) surgery.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ossicular prosthesis, partial",
   "INTENDED USE": "Intended to be implanted for the functional reconstruction of segments of the ossicular chain\n(mallues, incus, and/or stapes bones).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Otoscope, endoscopic",
   "INTENDED USE": "Intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or\nmiddle ear.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Tonsil knife",
   "INTENDED USE": "Intended for the removal of the tonsils during a surgical intervention.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Tracheal bistoury",
   "INTENDED USE": "Designed for opening abscesses or slitting up sinuses and/or fistulas in the trachea.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Middle ear mold",
   "INTENDED USE": "Amiddle ear mold is a preformed device that is intended to be implanted to reconstruct the middle\near cavity during repair of the tympanic membrane.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Fully-implantable middle ear\nimplant system",
   "INTENDED USE": "An implanted assembly of sterile devices intended to compensate for impaired hearing by\ntransmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via\nan external device.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Larynx prosthesis",
   "INTENDED USE": "A device used for replacement and restoration of the laryngeal function, or for maintenance of\npatency of the larynx.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Ossicular prosthesis, total",
   "INTENDED USE": "A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain\n(mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic\nmembrane to the inner ea to treat conductive hearing loss from traumatic or surgical injury,\notosclerosis, congenital fixation of the stapes, or chronic middle ear disease.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Otoscope, direct",
   "INTENDED USE": "Inteded for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing\nthrough the ear opening.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Soft-tissue surgical forceps,\nalligator",
   "INTENDED USE": "A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation\nof soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery].",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Epistaxis balloon",
   "INTENDED USE": "Device intended to control internal nasal bleeding by exerting pressure against the sphenopalatine\nartery.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Eustachian tube balloon\ndilation system",
   "INTENDED USE": "The system is intended for use in dilating the cartilaginous portion of the Eustachian tube for\ntreating persistent Eustachian tube dysfunction.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ear, nose, and throat electric\nor pneumatic surgical drill",
   "INTENDED USE": "An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the\nhandpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur , for\nthe controlled incision or removal of bone in the ear, nose, and throat area.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Hearing aid calibrator and\nanalysis system",
   "INTENDED USE": "A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate\nand assess the electroacoustic frequency and sound intensity characteristics emanating from a\nhearing aid, master hearing aid, group hearing aid or group auditory trainer.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Tympanic membrane contact\nhearing aid",
   "INTENDED USE": "A tympanic membrane contact hearing aid is a prescription device that compensates for impaired\nhearing by vibrating the tympanic membrane through a transducer that is in direct contact with the\ntympanic membrane.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Master hearing aid",
   "INTENDED USE": "Amaster hearing aid is an electronic device intended to simulate a hearing aid during audiometric\ntesting.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Active implantable bone\nconduction hearing system",
   "INTENDED USE": "The active implantable bone conduction hearing system is intended to compensate for conductive\nor mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical\nvibrations on the skull bone.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Battery-powered artificial\nlarynx",
   "INTENDED USE": "A battery-powered artificial larynx is an externally applied device intended for use in the absence of\nthe larynx to produce sound.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Partial ossicular replacement\nprosthesis",
   "INTENDED USE": "A partial ossicular replacement prosthesis is a device intended to be implanted for the functional\nreconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from\nthe tympanic membrane to the inner ear.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Total ossicular replacement\nprosthesis",
   "INTENDED USE": "A total ossicular replacement prosthesis is a device intended to be implanted for the total functional\nreconstruction of the ossicular chain and facilitates the conduction of sound waves from the\ntympanic membrance to the inner ear.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Mandibular implant facial\nprosthesis",
   "INTENDED USE": "Amandibular implant facial prosthesis is a device that is intended to be implanted for use in the\nfunctional reconstruction of mandibular deficits.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Sacculotomy tack (Cody tack)",
   "INTENDED USE": "A sacculotomy tack (Cody tack) is a device that consists of a pointed stainless steel tack intended\nto be implanted to relieve the symptoms of vertigo.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Nasal dilator",
   "INTENDED USE": "A nasal dilator is a device intended to provide temporary relief from transient causes of breathing\ndifficulties resulting from structural abnormalities and/or transient causes of nasal congestion\nassociated with reduced nasal airflow.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Tympanostomy tube with\nsemipermeable membrane",
   "INTENDED USE": "A tympanostomy tube with a semipermeable membrane is a device intended to be implanted for\nventilation or drainage of the middle ear and for preventing fluids from entering the middle ear\ncavity.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Transcutaneous air\nconduction hearing aid\nsystem",
   "INTENDED USE": "A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended\nto compensate for impaired hearing without occluding the ear canal.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Absorbent enteric stomal dressing",
   "INTENDED USE": "To be placed over a continent enteric stoma (surgically-created artificial\nopening between the intestines and the body surface throughwhich bodily\nwaste is drained from the intestines) to protect it from harmful external\ninfluences, which includes absorbent materials intended to protect the\nsurrounding skin from enteric fluids.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Anal fistula circular cutter",
   "INTENDED USE": "To be intended for the circumferential resection of tissue to treat simple anal\nfistula",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Anal fistula seton",
   "INTENDED USE": "A sterile implantable cord intended to be placed through an anal fistula tract\nand tied outside the fistula, forming a loop around the anus, to allow drainage\nthrough the fistula for tissue healing.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Anoscope, reusable",
   "INTENDED USE": "An endoscope with a rigid inserted portion intended for the visual examination\nand treatment of the anus and rectum.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Anoscope, single-use",
   "INTENDED USE": "A sterile endoscope with a rigid inserted portion intended for the visual\nexamination and treatment of the anus and rectum.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Barium enema catheter",
   "INTENDED USE": "A flexible tube designed to administer barium, a contrast medium, into the\nlower gastrointestinal tract by way of the rectum, for radiographic visualization\nof the area.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Bile duct prosthesis",
   "INTENDED USE": "An implantable artificial substitute for the tube-like structure that carries bile\nfrom the gallbladder to the duodenum.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Biliary drainage catheter",
   "INTENDED USE": "A flexible tube intended to be introduced percutaneously, for temporary or\nprolonged drainage of the biliary tract, for splinting of the bile duct during\nhealing, or for preventing stricture of the bile duct.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Biliary manometric catheter",
   "INTENDED USE": "A sterile, non-electrical flexible tube intended to be inserted into the biliary\ntree tomeasure pressures within the ducts, especially to evaluate sphincter of\nOddi function.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Catheter-balloon inflator,\nreprocessed",
   "INTENDED USE": "A sterile device designed to manually inflate and regulate the pressure of a\nballoon catheter (e.g., by injecting and aspirating fluid or air within the\nballoon), and todeflate the balloon during amedical procedure.It is typically\nused during angiography, angioplasty, gastrointestinal (GI), or sinuplasty\nprocedures.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Colonoscope positioning sleeve",
   "INTENDED USE": "A non-sterile endoscopic sheath with two inflatable balloons designed to be\nmounted on a colonoscope to position and stabilize the endoscope within the\nlarge intestine of a patient.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Colonoscope stiffener",
   "INTENDED USE": "Adedicated stiff wire that is inserted into a flexible colonoscope to allow the\nphysician to increase the stiffness of the colonoscope when extra rigidity is\nrequired during a colonoscopy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Colorectal sizer",
   "INTENDED USE": "A hand-held manual surgical instrument designed to assess colon and/or rectal\nlumen diameter to aid the selection of an appropriate size intraluminal stapler\n(i. e, the stapler head) for bowel anastomosis following transection.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Common bile duct dilator",
   "INTENDED USE": "A hand-held manual surgical instrument designed to dilate the common bile\nduct, i.e., the union of the cystic and hepatic ducts.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Duodenal bypass liner",
   "INTENDED USE": "A non-sterile stent-like device with a valve designed to be implanted in the\nduodenumwhere it is intended to reduce duodenal nutrient absorption from\nfood to facilitate obese patient weight loss.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Duodenal-jejunal bypass liner",
   "INTENDED USE": "A sterile stent-like implant designed to function as an impermeable barrier in\nthe duodenum and part of the jejunum for partially-digested food from the\nstomach (chyme) passing on its inside and bile/digestive enzymes passing on its\noutside, intended to treat type 2 diabetes mellitus and obesity.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Endoscope tissue removal cap",
   "INTENDED USE": "A sterile plastic tube designed to be placed onto the distal end of an endoscope\n(e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue\nduring electrosurgical treatment (e.g., for the treatment of Barrett<74>s\noesophagus).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Endoscopic biopsy valve, non-sterile",
   "INTENDED USE": "A non-sterile device intended to be fitted to an endoscope biopsy port to\nenable access for/exchange of endoscopic devices while maintaining\ninsufflation andminimizing leakage of biomaterial during an endoscopic\nprocedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Endoscopic biopsy valve, sterile",
   "INTENDED USE": "A sterile device intended to be fitted to an endoscope biopsy port to enable\naccess for/exchange of endoscopic devices while maintaining insufflation and\nminimizing leakage of biomaterial during an endoscopic procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Endoscopic cutting stapler connector",
   "INTENDED USE": "A rod-like component of an endoscopic cutting stapler intended to enable\nconnection between the stapler handpiece and the endpiece/loading unit.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Enema tube",
   "INTENDED USE": "A non-sterile, length of tubing that is used as a conduit between the enema bag\nand the enema tip for the delivery of the enema solution into the rectum.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Enteral feeding kit, adult/paediatric,\nnon-sterile",
   "INTENDED USE": "A collection of non-sterile devices that includes tubing and other materials\nintended to administer nutrient liquids directly into the stomach, duodenum, or\njejunum of an adult or paediatric (excludes infants) patient by means of gravity\nor an enteral pump.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Enteral feeding kit, adult/paediatric,\nsterile",
   "INTENDED USE": "A collection of sterile devices that includes tubing and other materials intended\nto administer nutrient liquids directly into the stomach, duodenum, or jejunum\nof an adult or paediatric (excludes infants) patient by means of gravity or an\nenteral pump.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Enteral feeding tube clearing kit",
   "INTENDED USE": "A collection of non-sterile compounds and devices intended to be used to\nprevent and/or remove, through biochemical action, an enteral formula clog in\nan in situ enteral feeding tube to maintain luminal patency.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Enteral feeding/decompression tube\nclearing stem",
   "INTENDED USE": "A non-sterile, sheath-covered device intended to be used tomechanically clear\na clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy\ntube, used for feeding and/or decompression, tomaintain luminal patency.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Enteral tube extension, non-sterile",
   "INTENDED USE": "Anon-sterile, thin, flexible tube intended for extracorporeal connection to an\nenteral feeding tube (e.g., nasogastric tube) to increase the length of tubing\nfrom the patient to an oral/enteral device (e.g., syringe) during enteral\nfeeding/medication administration or aspiration.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Enteral tube extension, sterile",
   "INTENDED USE": "A sterile, thin, flexible tube intended for extracorporeal connection to an\nenteral feeding tube (e.g., nasogastric tube) to increase the length of tubing\nfrom the patient to an oral/enteral device (e.g., syringe) during enteral\nfeeding/medication administration or aspiration.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Externally-propelled flexible video\ncolonoscope",
   "INTENDED USE": "Anon-sterile endoscope with a highly flexible sleeve and distal tip intended for\nthe visual examination of the entire adult colon [lower gastrointestinal (GI)\ntract].",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Fistula-repair biomatrix implant",
   "INTENDED USE": "A sterile, bioabsorbable, animal-derived substance intended to be injected into\na fistula tract (e.g., anal or rectal fistula) to close it by adding volume and\npromoting the ingrowth and neovascularization of host tissue.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible fibreoptic choledochoscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the choledoc, better known as the common bile\nduct (CBD).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video choledochoscope,\nsingle-use",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the biliary tract and related ducts [e.g., common\nbile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video colonoscope, reusable",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the entire colon [lower gastrointestinal (GI)\ntract].",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video colonoscope, single-\nuse",
   "INTENDED USE": "A sterile endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the entire colon [lower gastrointestinal (GI)\ntract].",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video duodenoscope,\nreusable",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the duodenum (the first part of the small\nintestine).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video duodenoscope, single-\nuse",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the duodenum (the first part of the small\nintestine).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video enteroscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the small intestine (the duodenum, jejunum, and\nileum).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video gastroduodenoscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the upper gastrointestinal (GI) tract\n[oesophagus, stomach, and duodenum (the first part of the small intestine),\nincluding the pancreas and the bile duct].",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video gastroscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the oesophagus and the stomach.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video oesophagoscope,\nreusable",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the oesophagus. It is inserted into the body\nthrough the mouth. Anatomical images are obtained via a camera incorporated\nat the distal end of the oesophagoscope and are shown on a monitor. This\ndevice is commonly used to examine abnormalities in the tissue structure and\nmucous lining of the oesophagus. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video oesophagoscope,\nsingle-use",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the oesophagus.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video pancreatoscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment in the pancreas.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gastrointestinal endoscopic clip, long-\nterm",
   "INTENDED USE": "A sterile clip intended to be implanted long-term (>30 days) within the\ngastrointestinal (GI) tract during an endoscopic procedure for endoscopic\nmarking, haemostasis, tissue approximation, closure of luminal perforations,\nand/or for treating mucosal/submucosal defects.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Gastrointestinal endoscopic clip,\nshort-term",
   "INTENDED USE": "A sterile clip intended to be placed short-term (<=30 days) within the\ngastrointestinal (GI) tract during an endoscopic procedure for endoscopic\nmarking, haemostasis, tissue approximation, closure of luminal perforations,\nand/or for treating mucosal/submucosal defects.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Gastrointestinal manometric\ncatheter, electronic",
   "INTENDED USE": "A non-sterile flexible tube with electronic sensors at the distal end intended to\nbe inserted through the nose or rectum into the gastrointestinal (GI) tract to\nevaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus,\nstomach, duodenum, small bowel, colon, and anorectal area) by measuring\npressure; it may additionally be intended to measure pH and electrical\nimpedance and contain a lumen.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gastrointestinal manometric\ncatheter, non-electronic",
   "INTENDED USE": "A non-sterile, non-electrical flexible tube intended to be inserted through the\nnose or rectum into the gastrointestinal (GI) tract for measuring pressure to\nassess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal\nmusculature and anal sphincter functions, typically in the evaluation of GI\ndisorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence].",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gastrointestinal ostomy tube pocket",
   "INTENDED USE": "A non-sterile, noninvasive pouch designed to be wrapped around the\nprotruding end of a gastrointestinal ostomy tube (e.g., gastrostomy or\njejunostomy tube) to hold and support it in order to ensure its stabilization on\nthe patient.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Gastrointestinal/airway foreign body\nretrieval basket",
   "INTENDED USE": "A flexible device intended to access the gastrointestinal (GI) tract, and/or the\nairway tree, via the working channel of an appropriate endoscope to\natraumatically remove foreign bodies during an endoscopic procedure; it may\nin addition be intended for removal of severed polyps and tissue samples\n(biopsy).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gastrostomy tube",
   "INTENDED USE": "A sterile, thin, flexible, hollow cylinder percutaneously inserted into the\nstomach, typically through puncture of the abdominal wall and stomach after\ndistention of the stomach by endoscopic methods. It is used to feed a patient\nwho has a physical disability that prevents oral feeding (e.g., a birth defect of\nthemouth, oesophagus, or stomach, or a neuromuscular condition that affects\nchewing and swallowing), and/or to provide drainage/decompression for the\nstomach when it is necessary to bypass a longstanding obstruction of the\nstomach outlet into the small intestine",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Gastrostomy tube Y-piece connector",
   "INTENDED USE": "A sterile connecting device shaped in the form of a \"Y\" intended for connection\nto the proximal end of a gastrostomy tube to enable administration of nutrient\nliquids and/or medication through the gastrostomy tube.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gastro-urological director",
   "INTENDED USE": "A slender, rod-like surgical instrument made of metal, typically with groove\nrunning along the centre of it distal shaft and/or continuing with an elongated\nmalleable wire loop, that is used to guide other devices or instruments into a\nselected intracorporeal location during a gastroenterological/urological (GU)\nprocedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gastro-urological probe",
   "INTENDED USE": "A slender, rod-like, hand-held manual surgical instrument, typically made of\nflexible metal with a blunt bulbous tip, designed for exploring\ngastroenterological/urological (GU) structures during a GU procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gastro-urological scoop",
   "INTENDED USE": "A heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged\ndistal end on a long thin shaft that is used to access and scrape tissue from the\ncommonhepatic/bile duct system during a gastroenterological/urological (GU)\nprocedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gravity enema set",
   "INTENDED USE": "A collection of devices intended to be used to deliver an injection of fluid (e.g.,\nsaline solution) into the rectum to facilitate evacuation of the large intestine.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Implantable gastric clamp",
   "INTENDED USE": "A sterile implantable device designed to isolate the lesser curvature segment of\nthe stomach (magenstrasse) to reduce stomach volume and facilitate weight\nloss in overweight/obese patients through a reduction in food consumption\nbased on an increased sense of satiety (fullness).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Jejunostomy tube",
   "INTENDED USE": "A sterile, thin, flexible, hollow cylinder percutaneously inserted into the\njejunum, typically through puncture of the abdominal wall and stomach after\ndistention of the gut by endoscopic methods. It is used to feed a patient who\nhas a physical disability that prevents oral feeding (e.g., a birth defect of the\nmouth, oesophagus, or stomach, or a neuromuscular condition that affects\nchewing and swallowing), and/or to provide drainage/decompression for the\nstomach when it is necessary to bypass a longstanding obstruction of the\nstomach outlet into the small intestine.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Laparoscopic cholangiography\ncatheter/needle",
   "INTENDED USE": "A sterile, flexible, single-lumen tube with a distal needle intended to puncture\nthe neck of the gallbladder (Hartmann<6E>s pouch) during laparoscopic\ncholangiography to allow injection of contrast media.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Laparoscopic grasping forceps,\nreprocessed",
   "INTENDED USE": "A sterile, rigid surgical instrument designed to be introduced through a\nlaparoscope primarily for grasping andmanipulating tissues during a\nlaparoscopic surgical procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Laparoscopic grasping forceps,\nreusable",
   "INTENDED USE": "A rigid surgical instrument designed to be introduced through a laparoscope\nprimarily for grasping andmanipulating tissues during a laparoscopic surgical\nprocedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Laparoscopic grasping forceps, single-\nuse",
   "INTENDED USE": "A sterile, rigid surgical instrument designed to be introduced through a\nlaparoscope primarily for grasping andmanipulating tissues during a\nlaparoscopic surgical procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Laparoscopic swab forceps",
   "INTENDED USE": "An instrument designed to grasp a pledget swab at the distal end to obtain\ncytological specimens and/or to perform blunt dissection during gynaecologic\nand/or other (e.g., cholecystectomy) laparoscopic procedures.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Manual enema device",
   "INTENDED USE": "A non-sterile device intended to be used to manually administer fluid (e.g.,\nsaline solution) into the rectum to facilitate evacuation of the large intestine\nthrough expansion of the lower intestinal tract and physical stimulation of\nperistalsis.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Manual enema device, reusable",
   "INTENDED USE": "Adevice intended to be used tomanually administer fluid (e.g., saline solution)\ninto the rectum to facilitate evacuation of the large intestine through\nexpansion of the lower intestinal tract and physical stimulation of peristalsis.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Manual rectal irrigation system",
   "INTENDED USE": "A portable assembly of manually-operated devices designed to be used by or\non a patient to irrigate the rectum with water, typically to provoke the\ndefecation reflex for the evacuation of the bowels to treat/prevent\nconstipation and reduce the risk of faecal incontinence.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Over-guidewire oesophageal dilator",
   "INTENDED USE": "A surgical instrument in the form of a slender, hollow cylinder made ofmetal,\nplastic or other suitable material, designed to dilate oesophageal\nstrictures/passages after being passed over a pre-positioned guidewire,\ntypically in sequentially increasing sizes. It is commonly used prior to and to\nassist in a gastroscopy and is available in a variety of sizes and flexibilities.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Paediatric-temperature\nnasogastric/orogastric tube",
   "INTENDED USE": "A sterile, thin, flexible, hollow cylinder designed as a paediatric or neonatal\nenteral feeding tube with an integrated temperature sensor that continuously\nmeasures oesophageal temperature.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Partially-implantable abdominal\nport/catheter",
   "INTENDED USE": "A sterile partially-implantable device intended to provide access to the\nperitoneal cavity for infusion (e.g., insulin, chemotherapeutic agents).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Percutaneous biliary biopsy\nprocedure kit",
   "INTENDED USE": "A collection of sterile devices intended to be used to obtain a tissue specimen\nfromwithin the biliary duct system for histological analysis by a percutaneous\napproach, typically under fluoroscopic visualization.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pharyngeal electrical stimulation\ncatheter",
   "INTENDED USE": "A sterile, flexible tubular device intended to deliver pharyngeal electrical\nstimulation for the treatment of neurogenic dysphagia.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Powered rectal/colostomy irrigation\nsystem",
   "INTENDED USE": "A portable assembly of battery-powered devices intended to be used by, or on\na patient, for the controlled introduction of a non-medicated solution (typically\nwater) into the rectum to treat faecal incontinence or constipation (rectal\nirrigation), and/or for colostomy site irrigation.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Probiotic oropharyngeal mucosa\ndressing",
   "INTENDED USE": "A non-sterile substance intended to be applied to the mucosa of the mouth\nand/or pharynx to facilitate saprophytic microflora colonization within the oral\ncavity/pharynx, typically following antibiotic therapy, bacterial infection, or\ninjury. It includes probiotic bacteria (e.g., Streptococcus salivarius,\nStreptococcus oralis) and compounds that create a barrier to facilitate growth\nof the probiotic bacteria.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Proctoscope, reusable",
   "INTENDED USE": "An endoscope with a rigid inserted portion intended for the visual examination\nand treatment of the rectum and anus.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Proctoscope, single-use",
   "INTENDED USE": "A sterile endoscope with a rigid inserted portion intended for the visual\nexamination and treatment of the rectum and anus.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Rectal irrigation kit",
   "INTENDED USE": "A collection of non-sterile devices intended to be used as part of a rectal\nirrigation system for the introduction of a non-medicated solution (typically\nwater) into the rectum for patients affected by faecal incontinence or\nconstipation.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Spring-loaded pneumoperitoneum\nneedle, reusable",
   "INTENDED USE": "A slender, sharply-pointed metal tube designed to introduce or remove gas\nfrom the peritoneal cavity as a therapeutic or surgical/radiological procedural\nmethod. It is often inserted into the peritoneal cavity for the purpose of\ninsufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum\nprior to abdominal endoscopy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Spring-loaded pneumoperitoneum\nneedle, single-use",
   "INTENDED USE": "A slender, sharply-pointed metal tube designed to introduce or remove gas\nfrom the peritoneal cavity as a therapeutic or surgical/radiological procedural\nmethod. It is often inserted into the peritoneal cavity for the purpose of\ninsufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum\nprior to abdominal endoscopy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Static magnetic anal plug",
   "INTENDED USE": "A non-sterile magnetic device designed to be inserted into the rectum by the\nuser and retained there for a specified period of time (e.g., 1 to 2 hours per day\nfor 10 to 20 days) to help reduce anal haemorrhoids with magnetism.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Stoma drainage catheter",
   "INTENDED USE": "A sterile flexible tube that is inserted into a stoma (an artificial opening in the\nbody, especially in the abdominal wall, made during a surgical procedure) to\ndrain bodily waste from an internal stoma container; normally directly into the\ntoilet.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Stoma support implant",
   "INTENDED USE": "A sterile, non-bioabsorbable device intended to be implanted into the\nabdominal wall during a gastro-urological ostomy procedure to reduce the risk\nof parastomal hernia by supporting the abdominal wall surrounding the stoma.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "TEM/TEO rectoscope, optical",
   "INTENDED USE": "An endoscope with a rigid inserted portion intended for surgical treatment of\nthe lower part of the bowel during transanal endoscopic microsurgery (TEM) or\ntransanal endoscopic operations (TEO).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "TEM/TEO rectoscope, video",
   "INTENDED USE": "An endoscope with a rigid inserted portion intended for surgical treatment of\nthe lower part of the bowel during transanal endoscopic microsurgery (TEM) or\ntransanal endoscopic operations (TEO).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Thermal-regulation orogastric tube",
   "INTENDED USE": "Anon-sterile, multi-lumen,multi-purpose tube intended for oral introduction\ninto the gastrointestinal (GI) tract for both: 1) enteral feeding/gastric\ndecompression; and 2) thermal regulation of the whole body via thermal\ntransfer across the oesophagus (to lower and alternatively elevate core body\ntemperature).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Bare-metal urethral\nstent, short-term",
   "INTENDED USE": "A sterile non-bioabsorbable tubular device intended to be placed\nshort-term (<= 30 days) in the urethra to facilitate urethral\npatency and an unimpeded flow of urine from the bladder; it is\ntypically used to relieve lower urinary tract symptoms (LUTS) due\nto benign prostatic hyperplasia (BPH).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Biliary/urinary stone\nretrieval basket, reusable",
   "INTENDED USE": "A flexible manual instrument designed to remove biliary and/or\nurinary stones (gallbladder and/or renal calculi) from the body\nduring an endoscopic procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Bladder neck spreader",
   "INTENDED USE": "A manual gastroenterology-urology surgical instrument with\nspecially designed moveable blades intended to be used to\nseparate and spread the bladder neck. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Bladder-emptying\nvibratory stimulator",
   "INTENDED USE": "A battery-powered, hand-held device intended to be used in the\nhome or healthcare facility by a patient to help initiate urination\nand facilitate complete bladder emptying through application of\nsmall mechanical vibrations to the lower abdomen to promote\nurethral sphincter relaxation.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Diaphragm wearable\nurinal",
   "INTENDED USE": "A non-sterile urine drainage device designed for men with\nincontinence consisting of a front piece with a scrotal support and\na leak-proof, flexible diaphragm through which the penis passes\ninto a closed cone-shaped tube connected to a leg bag into which\nthe urine is collected.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Draping incontinence\nliner",
   "INTENDED USE": "A non-sterile padded sheet intended to cover and protect a\ndevice/piece of furniture (e.g., wheelchair, bed, sofa) occupied by\nan incontinent person by catching and retaining urine.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Drip wearable urinal",
   "INTENDED USE": "A non-sterile urine drainage device designed for men to contain a\nmoderate leakage consisting of a front piece with an integrated\ntubular sheath that fits fully over the penis and into which\ndribbling urine is collected.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Electrohydraulic\nlithotripsy system",
   "INTENDED USE": "An assembly of devices that uses plasma-induced shock waves for\nthe intracorporeal fragmentation of stones (calculi) found in the\nkidney, ureter, and bladder.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Electrohydraulic/pneuma\ntic lithotripsy system\nprobe, urinary, single-use",
   "INTENDED USE": "A sterile, slender, rod-like device intended to be used as part of\nan intracorporeal lithotripsy system to transmit shock waves from\nelectrohydraulic or pneumatic sources directly to a calculus in the\nurinary tract (i.e., kidneys, ureters, and bladder), providing high-\nspeed fragmentation of the calculus in situ.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Filiform urethral bougie",
   "INTENDED USE": "An extremely thin, wire-like, manual surgical instrument designed\nfor traversing and exploring urethral strictures and/or dilating the\nurethra, introduced directly or through an appropriately-threaded\nurethral catheter.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible endoscopic stone\nretrieval forceps,\nreusable",
   "INTENDED USE": "A flexible manual device intended to be inserted through the\nworking channel of a compatible flexible endoscope to grasp and\nremove stones (e.g., calculi from the urinary tract) or foreign\nbodies during an endoscopic procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible fibreoptic\ncystonephroscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the\nvisual examination/treatment of the bladder, the urethra\n(including the prostate region), and the kidneys.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible fibreoptic\ncystoscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the\nvisual examination and treatment of the bladder and the urinary\ntract.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible fibreoptic\ncystourethroscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the\nvisual examination and treatment of the bladder and the urethra,\nincluding the prostate region.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible ureteral\nsheath/fibreoptic\ntelescope",
   "INTENDED USE": "A sterile device assembly intended to function as a flexible\nendoscope for the visual examination and treatment of body\ncavities/organs that can be accessed via the ureter for\ncystoscopic, nephroscopic, laparoscopic, and ureteroscopic\nprocedures.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video\ncystonephroscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the\nvisual examination/treatment of the bladder, urethra (including\nprostate region), and kidneys.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video\ncystoscope, reusable",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the\nvisual examination and treatment of the bladder and the urinary\ntract by introduction through the urethra.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video\ncystourethroscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the\nvisual examination and treatment of the bladder and the urethra,\nincluding the prostate region.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video\nnephroscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the\nvisual examination and treatment of the kidney.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video\nureterorenoscope,\nreusable",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the\nvisual examination and treatment of the ureter and the renal\npelvis.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video\nureteroscope, reusable",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the\nvisual examination and treatment of the ureter (the upper urinary\ntract that connects the kidney to the bladder).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Home faecal specimen\ncollection kit",
   "INTENDED USE": "A collection of non-sterile devices and materials intended to be\nused by a layperson to collect and mail a faecal (stool) sample to\na clinical laboratory for diagnostic testing or screening purposes\n(e.g., occult blood, cytology).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Hydraulic male urinary\nincontinence treatment\nsystem",
   "INTENDED USE": "An assembly of implantable devices intended to treat male\nurinary incontinence by applying pressure to partially/fully\nocclude the bladder neck and/or urethra, typically after radical\nprostatectomy or transurethral resection of the prostate.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Hydraulic male urinary\nincontinence treatment\nsystem port",
   "INTENDED USE": "An implantable component of a hydraulic male urinary\nincontinence treatment system intended to provide access to the\nsystem<65>s inflatable pad (e.g., cushion, balloon), for the intra-\nand/or postoperative introduction/removal of fluid (e.g., saline).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Hydraulic male urinary\nincontinence treatment\nsystem tubing",
   "INTENDED USE": "An implantable length of tube that functions as a component of a\nhydraulic male urinary incontinence treatment system and\nintended to provide connection between the system<65>s inflatable\npad (e.g., cushion, balloon) and the system<65>s port, for the intra-\nand/or postoperative introduction/removal of fluid (e.g., saline);\nit is typically made of silicone and metal.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Inflatable penile\nprosthesis",
   "INTENDED USE": "An inflatable/deflatable sterile device designed of several\ninterconnected components intended to be surgically implanted\nin a patient with erectile dysfunction (ED) [commonly known as\nimpotence] in order to achieve selective penile tumescence and\nrigidity adequate for vaginal intercourse",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Intermittent urethral\ncatheterization kit, non-\nsterile",
   "INTENDED USE": "A collection of non-sterile devices that includes a urological\ncatheter (with or without a urine drainage bag), a cap, and other\nrelated accessories intended for self-urinary catheterization.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Intermittent urethral\ncatheterization kit, sterile",
   "INTENDED USE": "A collection of sterile devices that includes a urological catheter\n(with or without a urine drainage bag), a cap, and other related\naccessories intended for self-urinary catheterization.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Intermittent urethral\ndrainage catheter,\nantimicrobial",
   "INTENDED USE": "A sterile, flexible or rigid, tube designed to be repeatedly inserted\nthrough the urethra, typically by the user (i.e., self-applied), to\nthe urinary bladder to provide short-term, episodic urine drainage\n(removed after each void), typically for an individual who is\nphysiologically incapable of voiding.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Laser lithotripsy system",
   "INTENDED USE": "An assembly of devices consisting of a specialized ureteroscope, a\nlaser resistant catheter, and a dedicated laser designed for the\nintracorporeal disintegration of ureteral stones (calculi).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Lithotrite",
   "INTENDED USE": "A hand-held manual surgical instrument designed for the\nmechanical crushing of renal stones (calculi) in the urinary tract\nand/or bladder",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Male urinary outflow\nanalysis system",
   "INTENDED USE": "A mains electricity (AC-powered) assembly of devices intended to\nbe used to measure urine flow rate and to estimate iso-\nvolumetric bladder pressure in men with the use of an inflatable\npenile cuff. It typically consists of a dedicated computer and\napplication software, an automatic cuff inflation/deflation unit, a\nsingle-use penile cuff, and a load-measuring cell/stand.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Male urinary outflow\nanalysis system cuff",
   "INTENDED USE": "A non-sterile inflatable cuff that is a component of a male urinary\noutflow analysis system.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Manometric catheter\nsheath",
   "INTENDED USE": "A non-sterile, synthetic polymer sleeve intended to cover/protect\nand prevent contamination of a manometric catheter (including\nbarostat catheter).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Microwave hyperthermia\nsystem catheter,\nprostatic-ablation,\nreusable",
   "INTENDED USE": "A thin rod intended to be used as part of a hyperthermia system\nto treat disorders of the prostate [e.g., cancer, benign prostatic\nhyperplasia (BPH), prostatitis] through the local application of\nheat from microwaves.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Perineal orifice\nincontinence-control\nelectrical stimulation\nsystem, remote control",
   "INTENDED USE": "An assembly of battery-powered, remote-controlled devices\ndesigned for intravaginal pelvic floor exercise to treat urinary\nincontinence and other pelvic problems in women (e.g., pelvic\npain and sexual dysfunction) through the application of electrical\nstimuli to the muscles of the pelvic floor.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Piezoelectric lithotripsy\nsystem",
   "INTENDED USE": "An assembly of devices that non-invasively disintegrates stones\n(i.e., calculi) by sending focused shock waves from outside the\nbody produced by a piezoelectric generator.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Pyeloscope",
   "INTENDED USE": "An endoscope with a rigid inserted portion intended for the visual\nexamination and treatment of the renal pelvis and major or minor\ncalyces.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Rigid cystoscope",
   "INTENDED USE": "An endoscope with a rigid inserted portion intended for the visual\nexamination and treatment of the bladder and the urinary tract.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Rigid urethroscope",
   "INTENDED USE": "An endoscope with a rigid inserted portion intended for the visual\nexamination and treatment of the urethra (the muscular tube\nthat leaves the urinary bladder for the excretion of urine).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Rigid video\nureterorenoscope",
   "INTENDED USE": "A sterile endoscope with a rigid or semi-rigid inserted portion\nintended for the visual examination and treatment of the ureter\nand the renal pelvis; some types may have a flexible tip at the\ndistal end of the inserted portion.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Spark-gap lithotripsy\nsystem",
   "INTENDED USE": "An assembly of devices that non-invasively disintegrates stones\n(i.e., calculi) by sending focused shock waves from outside the\nbody produced by a spark-gap generator.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Suprapubic needle,\nsurgical, reusable",
   "INTENDED USE": "A hand-held manual surgical instrument designed with a sharp\npyramidal or conical point at the distal end to percutaneously\npuncture the lower abdominal wall to provide suprapubic access\nfor surgical repair, typically to position a sling used in the\ntreatment of female stress urinary incontinence (SUI) associated\nwith bladder prolapse.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ureteral patency kit",
   "INTENDED USE": "A collection of devices intended to assist treatment of a blocked\nureter and to help maintain ureteral patency through natural\norifice or percutaneous access.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Urethral drainage\ncatheter punch",
   "INTENDED USE": "A hand-held manual instrument designed for cutting a small hole\n(e.g., 0.3 mm diameter) into the distal end of a closed Foley\ncatheter (usually 14.0 French or larger) to form a \"Council tip\nFoley catheter\", allowing it to be placed over a guidewire or\nureteral catheter.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Urethral/suprapubic\ncatheter valve-connector",
   "INTENDED USE": "A small, sterile valve intended to be connected to a urethral\nand/or suprapubic catheter to allow intermittent bladder\ndrainage/filling (as an alternative to continuous drainage).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Urinary-incontinence\nvaginal insert, reusable",
   "INTENDED USE": "A non-sterile, device intended to be inserted into the vagina in\norder to relieve mixed or stress urinary incontinence in an adult\nfemale by providing urethral support when pressure is\ntransferred from the abdomen to the pelvic floor area (e.g. upon\ncoughing, laughing, sneezing, exertion).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Liquid crystal forehead temperature strip",
   "INTENDED USE": "A liquid crystal forehead temperature strip is a device\napplied to the forehead that is used to indicate the\npresence or absence of fever, or to monitor body\ntemperature changes.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Bed exit monitor,Fall prevention",
   "INTENDED USE": "Intended to be placed under mattress and used to\nindicate by an alarm or other signal when a patient\nattempts to leave the bed.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Electronic monitor for gravity flow infusion\nsystems",
   "INTENDED USE": "Inteded to electroncially monitor the amount of fluid being\ninfused into a patient.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Electrically powered spinal fluid pressure monitor",
   "INTENDED USE": "Inteded to measure spinal fluid pressure by the use of a\ntransducer which converts spinal fluid pressure into an\nelectrical signal.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Spinal fluid manometer",
   "INTENDED USE": "A spinal fluid manometer is a device used to measure\nspinal fluid pressure using nnedle and graduated column.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Stand-on patient scale",
   "INTENDED USE": "Intended for medical purposes that is used to weigh a\npatient who is able to stand on the scale platform.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Patient scale",
   "INTENDED USE": "A patient scale is a device intended for medical purposes\nthat is used to measure the weight of a patient who cannot\nstand on a scaleby placing scale under a bed or chair to\nweigh both the support and the patient.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Sterilization process indicator (Biological)",
   "INTENDED USE": "A biological sterilization process indicator is a device\nintended for use by a health care provider to accompany\nproducts being sterilized through a sterilization procedure\nand tomonitor adequacy of sterilization on medical device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Therapeutic medical binder.",
   "INTENDED USE": "Intended for medical purposes and that can be secured by\nties so that it supports the underlying part of the body or\nholds a dressing in place like abdominal, breast and\nperineal binder.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Burn sheet.",
   "INTENDED USE": "Inteded to wrap aroung a burn victim to retain body heat,\nto absorb wound exudate, and to serve as a barrier against\ncontaminants",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Neonatal eye pad.",
   "INTENDED USE": "A neonatal eye pad is an opaque device used to cover and\nprotect the eye of an infant during therapeutic procedures,\nsuch as phototherapy.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Neonatal incubator.",
   "INTENDED USE": "A neonatal incubator is a device in which an infant may be\nkept in a controlled environment (humidity, temperature,\noxygen etc) for medical care.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Neonatal transport incubator.",
   "INTENDED USE": "Transport incubator is a device in which an infant may be\nkept in a controlled environment (humidity, temperature,\noxygen etc) while being transported for medical care.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Pressure infusor for an I.V. bag.",
   "INTENDED USE": "Device inteded to inflate and increases the pressure on the\nI.V. bag to assist the infusion of the fluid",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Intravascular administration set, automated air\nremoval system.",
   "INTENDED USE": "Inteded to detect and automatically remove air from an\nintravascular administration set with minimal to no\ninterruption in the flow of the intravascular fluid.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Patient care reverse isolation chamber.",
   "INTENDED USE": "Device inteded protects a patient who is undergoing\ntreatment for burns or is lacking a normal\nimmunosuppressive defense due to therapy or congenital\nabnormality.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Jet lavage.",
   "INTENDED USE": "A jet lavage is a device used to clean a wound by a pulsatile\njet of sterile fluid.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Patient lift, Electrcially powered",
   "INTENDED USE": "Inteded to lift and transport patients in hsoptial in the\nhorizontal or other required position from one place to\nanother, as from a bed to a bath.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "RemoteMedicationManagement System.",
   "INTENDED USE": "The system is intended to store the patient's prescribed\nmedications in a delivery unit, to permit a health care\nprofessional to remotely schedule the patient's prescribed\nmedications, to notify the patient when the prescribed\nmedications are due to be taken, to release the prescribed\nmedications to a tray of the delivery unit accessible to the\npatient on the patient's command, and to record a history\nof the event for the health care professional.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Surgical Light, Single or Multi dome",
   "INTENDED USE": "Intended for medical purposes that is used to illuminate\nbody surfaces and cavities during Surgery.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Medical examination light, AC powered or Battery",
   "INTENDED USE": "Intended for medical purposes that is used to illuminate\nbody surfaces and cavities during a medical examination.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Skin pressure protectors.",
   "INTENDED USE": "A skin pressure protector is a device intended to reduce\npressure on the skin over a bony prominence to reduce the\nlikelihood of the patient's developing decubitus ulcers\n(bedsores)",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Medical ultraviolet air purifier.",
   "INTENDED USE": "A medical ultraviolet air purifier is a device intended for\nmedical purposes in hospital/clinic to destroy bacteria in\nthe air by exposure to ultraviolet radiation.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ultraviolet (UV) radiation chamber disinfection\ndevice.",
   "INTENDED USE": "An ultraviolet (UV) radiation chamber disinfection device is\nintended for the low-level surface disinfection of non-\nporous medical device surfaces by dose-controlled UV\nirradiation.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Body waste receptacle.",
   "INTENDED USE": "A body waste receptacle is a device intended for medical\npurposes that is not attached to the body and that is used\nto collect the body wastes of a bed patient.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Vacuum-powered body fluid suction apparatus.",
   "INTENDED USE": "A vacuum-powered body fluid suction apparatus is a\ndevice used to aspirate, remove, or sample body fluids.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Medical washer-disinfector.",
   "INTENDED USE": "Amedical washer-disinfector is a device that is intended\nfor general medical purposes to clean, decontaminate,\ndisinfect, and dry surgical instruments, anesthesia\nequipment, hollowware, and other medical devices.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Hydrogen Peroxide Gas Plasma Sterilization\nSystem",
   "INTENDED USE": "Intended for sterilization/disinfection of both metal and\nnonmetal/polymer based medical devices.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Blood grouping slides",
   "INTENDED USE": "Blood grouping slides are glass surfaces intended to\nperform the test for finding the blood group.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Blood bank pipettes",
   "INTENDED USE": "Blood bank pipettes are disposable blood handling\nequipment intended to transfer blood fron one surface to\nother.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Bloodmixing and blood weighing devices",
   "INTENDED USE": "A blood mixing device is a device intended for medical\npurposes that is used to mix blood or blood components by\nagitation. Also intended to weigh blood or blood\ncomponents as they are collected.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Blood Vacutainer",
   "INTENDED USE": "Intended for the drawing of a predetermined volume of\nblood using vaccum to a container containing\nEthylenediaminetetraacetic acid.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Blood bank centrifuge",
   "INTENDED USE": "Intended to separate blood components of a suspension by\napplication of centrifugal force.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Environmental chamber for storage of platelet\nconcentrate",
   "INTENDED USE": "A refrigerated environmental chamber for storage of\nplatelet concentrate is a device used to hold platelet-rich\nplasma within a preselected temperature range",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Blood storage refrigerator",
   "INTENDED USE": "Thsese are devices intended for medical purposes that are\nused to preserve blood and blood products by storing them\nat cold or freezing temperatures.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Heat-sealing device",
   "INTENDED USE": "A heat-sealing device is a device intended for medical\npurposes that uses heat to seal plastic bags containing\nblood or blood components.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Distractor/Retractors",
   "INTENDED USE": "A surgical device used to separate connected surfaces, and to retain their positions to allow a surgical\noperation to be performed.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Suction system\nportable,\nElectrical/Pneumatic",
   "INTENDED USE": "A device that generates negative pressure used for such treatment as the aspiration of liquid or granular\nsubstances.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Suction system\noperated by vacum",
   "INTENDED USE": "A device used for such treatment as the aspiration of liquid or granular substances by using negative\npressure supplied by the hospital's medical gas supply system at bed side for using on patient.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Operation table\nsystem",
   "INTENDED USE": "A complete surgical table system intended change the patient's position and enable attaching various\ntable accessories that aid in surgery.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "General-purpose\ndiagnosis/treatment\ntable",
   "INTENDED USE": "A table for general diagnosis and procedures in examination room to aid in patient examination.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Surgical light system",
   "INTENDED USE": "An illuminator device intended to providing optimial light and colour renderingn to aid in performing\nsurgery.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Hemostatic clip\napplier",
   "INTENDED USE": "A surgical device designed to apply a hemostatic clip for ligation of a blood vessel.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Hemostatic knife",
   "INTENDED USE": "The blade intended to transmits heat directly to body tissues to achieve hemostasis.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Scalpel",
   "INTENDED USE": "An instrument used to sever and separate body tissues during surgery.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Scalpel blade",
   "INTENDED USE": "A blade intended to be attached to the handle of scalpel.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Surgical forceps",
   "INTENDED USE": "A surgical or dental device that is used to clamp and sever the cartilage, bone and other hard tissues.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "General-purpose\nelectrosurgical unit",
   "INTENDED USE": "A unit used to resect/ablate the tissue or to coagulate the incision/wound site with high-frequency\nwaves.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Long-term use\nenterostomy feeding\ntube",
   "INTENDED USE": "A hollow device to be placed surgically in the stomach, duodenum or jejunum to provide enteral\nnutrition. It is for long-term use.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Gastrostomy tube for\nlong-term use",
   "INTENDED USE": "A hollow device to be placed surgically in the stomach, duodenum or jejunum for enteral nutrition, etc.\nIt is for long-term use.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Warming high-flow\ninfusion pump",
   "INTENDED USE": "A device to be used for heating and rapidly infusing blood or other fluids during surgical procedures\ninvolving major bleeding, or for burns or injuries.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "High-flow blood\ntransfusion pump",
   "INTENDED USE": "A device to be used for rapidly infusing blood or other fluids during surgical procedures involving major\nbleeding, or for burns or injuries.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Medical Device\nName",
   "INTENDED USE": "Intended use",
   "RISK BASED CLASSIFICATION": "INDIA"
 },
 {
   "MEDICAL DEVICE NAME": "Activated-oxygen\ngenerator",
   "INTENDED USE": "It is a device that makes activated oxygen (singlet oxygen) which is mixed\nwith room air and produces activated water as a by-product.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Aerosol inhalation\nmonitor",
   "INTENDED USE": "It is a device that enables a medical professional to objectively assess in\ndetail how the test subject uses their inhaler.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Airway device\ncleaning utensil",
   "INTENDED USE": "A hand-held device intended to be used to clean an in situ and ex situ\nairway device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Airway tube forceps",
   "INTENDED USE": "A hand-held instrument used for grasping a tube for its insertion and/or\nextraction into/from the airways, or for grasping obstructive objects for\ntheir removal from the airways.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Argon gas analyser",
   "INTENDED USE": "An instrument intended to measure the concentration (partial pressure) of\nargon (Ar) in a gas mixture sample to aid in determining a patient's\nventilatory status.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Artificial airway tube\ncuff pressure monitor",
   "INTENDED USE": "A device intended to intermittently or continuously measure the internal\npressure in the cuff of an endotracheal (ET)/endobronchial/tracheostomy\ntube when this has been situated into the tracheal passage.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Artificial airway\nwashing/disinfection\njar",
   "INTENDED USE": "A container intended to hold artificial airway devices to facilitate their\nwashing/disinfection.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Breathing circuit bag",
   "INTENDED USE": "A device intended to store breathing gas during the respiratory cycle.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Breathing circuit\nwasher/disinfector",
   "INTENDED USE": "A device intended for the cleaning and high-level disinfection of breathing\ncircuit components used in respiratory therapy and anaesthesia\nequipment.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Bronchoscope",
   "INTENDED USE": "An endoscope with an inserted portion intended for the visual examination\nand treatment of the trachea, primary bronchi, and upper regions of the\nlungs and take biopsies and sample of secretions.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Dry salt therapy\ndevice",
   "INTENDED USE": "A hand-held inhaler prefilled with salt crystals and used to provide an\ninhalation of salt particles through the mouth and into the bronchial\nairways to induce natural self-cleansing mechanisms that flush away the\nimpurities from the surface of cells and mechanically clean the airways.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Electroacoustical\nairway secretion-\nclearing system",
   "INTENDED USE": "An assembly of devices designed to provide externally applied vibrations\nto the chest wall of a patient via an electroacoustical transducer (the\napplicator) to loosen excessive airway secretions to promote airway\nclearance and improve bronchial drainage for patients with respiratory\ndisease.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Electronic\noesophageal\nstethoscope",
   "INTENDED USE": "An electronic listening device designed to be inserted into a patient's\noesophagus to listen to heart and breathe sounds, typically while the\npatient is under anaesthesia.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Endotracheal tube\nintroducer",
   "INTENDED USE": "A device designed to help with the insertion of an endotracheal (ET) tube\ninto the airways of a patient during intubation",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Exhaled-gas\noesophageal\nintubation detector",
   "INTENDED USE": "A device designed to verify proper endotracheal (ET) tube placement by\ndetecting/assessing escaping levels of exhaled carbon dioxide (CO2)\nduring airway management disclosing potential incorrect intubation.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal pulse oximeter",
   "INTENDED USE": "A photoelectric device designed for the monitoring of intrapartum foetal\noxygen saturation (FSpO2) in the presence of a non-reassuring foetal\nheart rate (FHR) pattern during labour.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gas pipeline/supply\nsystem air\ncompressor",
   "INTENDED USE": "A device designed to create compressed medical grade air, and supply it\nto a hospital or institution's gas pipeline/supply system for patient use.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Heated respiratory\nhumidifier",
   "INTENDED USE": "A device designed to heat and humidify air/oxygen inspired by a patient to\nhelp maintain the mucous membranes of the respiratory tract typically\nduring periods of prolonged respiratory support/therapy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Home-use sleep\napnoea recording\nsystem",
   "INTENDED USE": "A device intended to continuously measure and record patient\nphysiological parameters during sleep in the home, to facilitate the\ndiagnosis of sleep apnoea.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Medical/surgical string",
   "INTENDED USE": "A sterile slender cord or thick thread, medical grade, designed to\ntemporarily lift vessels, hold tracheostomy tubes in place, or assist in\nstabilizing various organs, medical instrumentation and accessories",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Monitoring spirometer",
   "INTENDED USE": "A device designed to measure continuously a patient's tidal volume or\nminute volume for the evaluation of the patient's ventilatory status.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Negative-pressure\nventilator",
   "INTENDED USE": "An automatic cycling machine used to assist or control alveolar\nrespiration that exerts a negative pressure on the external surface of the\nchest wall, expanding the chest and moving air into the lungs.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Nitrogen monoxide\nanalyser",
   "INTENDED USE": "A device intended to measure nitric oxide (NO), in exhaled air to facilitate\ndiagnosis and management of asthma.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Nitrous oxide analyser",
   "INTENDED USE": "An instrument used to measure the concentration of nitrous oxide (N2O)\nin a sample of a gas mixture taken from an enclosed environment such as\na healthcare facility, a compressed medical air or gas system, and/or\ndevices used for anaesthesia administration or respiratory therapy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Oxygen concentrator",
   "INTENDED USE": "A device designed to concentrate oxygen (O2) from ambient air and\ndeliver the concentrated O2 to patient.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pneumatic chest\npercussor",
   "INTENDED USE": "A hand-held pneumatic device designed to provide external vibrations to\nthe chest wall of a patient to loosen excessive airway secretions to\npromote airway clearance and improve bronchial drainage for patients\nwith respiratory disease.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Public respirator (2\nply, 3 ply face mask)",
   "INTENDED USE": "A filtering mask designed to be placed over the nose and mouth of a\nmember of the general public to permit normal breathing while protecting\nthe wearer from exposure to pathogenic biological airborne particulates\nduring a public health medical emergency.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pulmonary function\nanalysis system",
   "INTENDED USE": "A device used to measure the function of the respiratory system in adults\nand compliant children.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pulse oximeter",
   "INTENDED USE": "A device intended for the transcutaneous measurement and display of\nhaemoglobin oxygen saturation (SpO2).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Thoracic suction\npump",
   "INTENDED USE": "A device intended to generate negative pressure specifically for\naspiration, to remove fluids, secretions and air to allow for the normal\nexpansion/function of the lungs and/or mediastinum.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Tongue-adjustment\nsleep apnoea\ntreatment system",
   "INTENDED USE": "An assembly of devices intended for home management of obstructive\nsleep apnoea (OSA) by monitoring breathing parameters during sleep to\ndetect the onset of an apnoea event and reducing pharyngeal obstruction\nby the tongue.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Tracheostoma\nprotective filter",
   "INTENDED USE": "A device designed as a filter for protecting a stomal opening in the\nwindpipe against harmful external influences.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Tracheostoma\nprotector",
   "INTENDED USE": "A patient-worn device in the form of a patch, collar, or cloth designed to\nbe fastened around the neck to protect a tracheostoma orifice against\nharmful external influences. It is not intended to be used as a shower\nshield.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Tracheostomy tube\nlubricant",
   "INTENDED USE": "A substance made of oil designed to be applied by healthcare staff or a\npatient to the outer surface of a tracheostomy tube inner cannula to\nfacilitate its easy sliding into the outer cannula.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Tracheotome",
   "INTENDED USE": "A surgical instrument designed to cut an opening into the trachea\n(windpipe) through the anterior surface of the neck to create an artificial\nairway (tracheotomy).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Transcutaneous blood\ngas monitoring system",
   "INTENDED USE": "An assembly of devices designed for the continuous and transcutaneous\nmeasurement of a patient's blood gas parameters detected through the\njugular vein (SjvO2).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ultrasonic cough\nstimulation system",
   "INTENDED USE": "An assembly of devices designed to stimulate a reflex cough using\nultrasound in a patient who cannot cough on command, typically\nrespiratory patients with cortical insufficiency or the very young/elderly, to\nhelp clear the lungs of secretions and aspirated materials.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ultrasonic respiratory\nhumidifier",
   "INTENDED USE": "A device designed to agitate water into micro-particles with ultrasound to\nadd moisture to the flow of air/gases administered to a patient via a\nbreathing tube/circuit.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Cranial trephine,",
   "INTENDED USE": "Intende as a neurosurgical blade used to cut/remove circular sections of the skull vault\n(calvarium) to provide access to the interior",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Craniotomy power tool system\nhandpiece",
   "INTENDED USE": "Intended to be used to rotate a cranial cutting tool (i.e., a drill bit, bur, trephine or\nperforator) in order to produce a hole or holes in the skull vault (calvarium).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cryogenic surgical device.",
   "INTENDED USE": "A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions\nin nervous tissue by the application of extreme cold to the selected site",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Cutaneous electrode.",
   "INTENDED USE": "A cutaneous electrode is an electrode that is applied directly to a patient's skin either to\nrecord physiological signals (e.g., the electroencephalogram) or to apply electrical\nstimulation",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Deep brain electrical\nstimulation system",
   "INTENDED USE": "Designed to apply electrical stimuli to specific areas of the deep brain for the treatment of\nmovement disorders, psychiatric disorders and/or to treat chronic, severe, intractable pain.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Deep brain electrical\nstimulation system lead",
   "INTENDED USE": "Intended to be implanted in specific areas of the deep brain and used along with deep\nbrain electrical simulation system.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Depth electrode.",
   "INTENDED USE": "A depth electrode is an electrode used for temporary stimulation of, or recording electrical\nsignals at, subsurface levels of the brain",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Diagnostic peripheral nerve\nelectrical stimulation system",
   "INTENDED USE": "Intended to apply electrical stimuli in one peripheral region of the body while the response\nis monitored in another peripheral region.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Diagnostic somatosensory\ntactile stimulation system",
   "INTENDED USE": "Intended to be used to apply tactile stimuli to the body (e.g., pneumatic activation of a\nmembrane to the fingers and lips) typically for evoked response procedures to investigate\nthe function and potential disorders of the brain.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Diskectomy system,\npercutaneous, automatic",
   "INTENDED USE": "Intended for the percutaneous (through the skin) removal of the nucleus pulposus from\nthe lumbar disc.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Dura mater sealant",
   "INTENDED USE": "Intended to be applied to sutured dura mater to prevent cerebrospinal fluid (CSF) leakage\nduring healing.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Echoencephalograph.",
   "INTENDED USE": "An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and\ndoppler systems) that uses noninvasive transducers for measuring intracranial interfaces\nand blood flow velocity to and in the head",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Ejaculation electrical\nstimulation system",
   "INTENDED USE": "Intended to apply electrical stimuli to the nerves that control ejaculation.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Electroconvulsive therapy\nsystem",
   "INTENDED USE": "Intended to apply strong electrical stimuli to a patient's brain to induce convulsions and\nloss of consciousness, typically to treat major depression, schizophrenia, or mania.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Electroencephalogram (EEG)\nsignal spectrum analyzer.",
   "INTENDED USE": "An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the\nfrequency content or power spectral density of the electroencephalogram (EEG) signal",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gait-enhancement electrical\nstimulation system, external",
   "INTENDED USE": "Intended to improve the gait in a patient suffering from partial paralysis of the lower\nextremities or other neuromuscular disorders by applying external electrical simulation.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gait-enhancement electrical\nstimulation system,\nimplantable",
   "INTENDED USE": "Intended to improve the gait in a patient suffering from partial paralysis of the lower\nextremities or other neuromuscular disorders by applying internal electrical simulation.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Gustometer",
   "INTENDED USE": "Intended to measure the threshold of a patient's taste by applying a variable direct current\nto the tongue.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Hand\ndynamometer/pinchmeter,\nelectronic",
   "INTENDED USE": "A electronically powered instrument intended to assess neuromuscular function by\nmeasuring the force or power exerted by the muscles of the hand/forearm to\nsqueeze/pinch an object and as part of interactive rehabilitation.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Hand\ndynamometer/pinchmeter,\nmechanical",
   "INTENDED USE": "A mechanical instrument intended to assess neuromuscular function by measuring the\nforce or power exerted by the muscles of the hand/forearm to squeeze/pinch an object\nand as part of interactive rehabilitation.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Home seizure monitoring\nsystem",
   "INTENDED USE": "Intended to detect and record a seizure by continuous measurement of one or more\nphysical/physiological parameters (e.g., body motion, electrical activity of the heart or\nskeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home;\nsome types may also be used in clinical settings.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Human dura mater.",
   "INTENDED USE": "Human dura mater is human pachymeninx tissue intended to repair defects in human\ndura mater",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Implantable intrathecal infusion\npump, programmable",
   "INTENDED USE": "Intended to be implanted in a patient for the storing and subarachnoid (intrathecal)\nadministration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable\npain and muscle spasms of malignant or non-malignant origin.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Implantable lumbar\nneuromuscular electrical\nstimulation system\nprogrammer",
   "INTENDED USE": "Intended to be used by a healthcare professional to telemetrically program the implantable\n( lumbar neuromuscular electrical stimulation system) pulse generator component with\npatient-specific parameters.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Implantable lumbar\nneuromuscular electrical\nstimulation system pulse\ngenerator",
   "INTENDED USE": "Intended to deliver episodic electrical stimulation to nerves that innervate lumbar muscles\nto elicit contraction for the treatment of chronic low back pain (CLBP).",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Implantable pulse generator\nmesh bag, bioabsorbable",
   "INTENDED USE": "Intended to envelop an implantable pulse generator (IPG) (e.g., cardiac\npacemaker/defibrillator, neurostimulator) to stabilize the implant in the subcutaneous\npocket in which it is implanted.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Implantable sleep apnoea\ntreatment system",
   "INTENDED USE": "Intended to deliver electrical stimulation to the hypoglossal nerve [targeted hypoglossal\nnerve stimulation (THN)] for the home management of obstructive sleep apnoea (OSA).",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Interferential electrical\nstimulation system",
   "INTENDED USE": "Intendedto relieve/manage intractable pain; some include additional electrodes to\nprovide other types of electrical stimuli or suction for therapeutic massage.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Intracranial pressure monitor\ndevice",
   "INTENDED USE": "Intended for intermittent or continuous measurement and display of intracranial pressure\n(ICP). It is used in conjunction with an invasive intracranial device.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Intramuscular\ndiaphragm/phrenic nerve\nelectrical stimulation system",
   "INTENDED USE": "Intended to provide ventilatory support to a patient with diaphragm dysfunction of\nneuromuscular origin through electrical stimulation of the phrenic nerve to contract the\ndiaphragm rhythmically (using intramuscular electrodes) and cause the patient to draw\nbreath in a manner similar to natural breathing.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Intramuscular\ndiaphragm/phrenic nerve\nelectrical stimulation system\nprogrammer",
   "INTENDED USE": "Intended to change, telemetrically, one or more of the operating parameters (the\nprograms) of an intramuscular diaphragm/phrenic nerve electrical stimulation system\nexternal pulse generator (EPG).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Intranasal cooling system",
   "INTENDED USE": "Intended for rapid cooling induction in patients where temperature reduction is clinically\nindicated (e.g., following a cerebral ischemic event, during cardiac arrest) to help\nmimimize damage to the brain and heart.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Intranasal lacrimal\nneurostimulator",
   "INTENDED USE": "Intended to be used in the home to provide electrical stimulation to sensory neurons of the\nnasal cavities to acutely increase tear production as treatment for aqueous deficient dry\neye.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Invasive-detection\nphysiological monitor",
   "INTENDED USE": "Intended for continuous or intermittent measurement, display and/or recording of several\ninvasively-detected physiological parameters [e.g., intracranial pressure (ICP),\ncompartmental pressure].",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Leukotome",
   "INTENDED USE": "Intended to cut brain tissue (i.e., cutting white matter, leukotomy).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Magnetoencephalography\nsystem",
   "INTENDED USE": "Intended to non-invasively detect, measure, and display bio-magnetic signals produced by\nelectrically-active cortical brain tissue, and that provide diagnostic information about the\nlocation of the active tissue responsible for cognitive brain functions relative to the\nsurrounding brain anatomy",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Manual goniometer",
   "INTENDED USE": "Inteded to be used in a clinical setting to measure the range of motion of the limb of a\npatient by measuring the angle of movement achieved at the joint.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Manual surgical saw, flexible",
   "INTENDED USE": "Intended for cutting bone through a sawing action during neurological or orthopaedic\nsurgery.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Meningeal prosthesis",
   "INTENDED USE": "Intended to repair the meningeal membrane (meninges).",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Nasopharyngeal electrode.",
   "INTENDED USE": "A nasopharyngeal electrode is an electrode which is temporarily placed in the\nnasopharyngeal region for the purpose of recording electrical activity",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Needle electrode.",
   "INTENDED USE": "A needle electrode is a device which is placed subcutaneously to stimulate or to record\nelectrical signals",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Nerve conduction velocity\nmeasurement device.",
   "INTENDED USE": "A nerve conduction velocity measurement device is a device which measures nerve\nconduction time by applying a stimulus, usually to a patient's peripheral nerve. This device\nincludes the stimulator and the electronic processing equipment for measuring and\ndisplaying the nerve conduction time",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Non-electroencephalogram\n(EEG) physiological signal\nbased seizure monitoring\nsystem.",
   "INTENDED USE": "A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring\nsystem is a noninvasive prescription device that collects physiological signals other than\nEEG to identify physiological signals that may be associated with a seizure",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Nonpowered neurosurgical\ninstrument.",
   "INTENDED USE": "A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand\ninstrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It\nincludes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges,\nhooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade\nholders, blade breakers, probes, etc",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Olfactometry system",
   "INTENDED USE": "Intended to determine the response of humans to odours delivered through the nose,\nincluding irritants.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Otoacoustic emission system",
   "INTENDED USE": "Intended to record and analyse the faint sounds hair cells in the inner ear emit in\nresponse to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of\nfunction in the ear during diagnostic evaluation and/or neonatal screening.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Percussion hammer, manual",
   "INTENDED USE": "Intended to be used by an examining physician to gently tap near a patient's joints to test\nreflexes.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Percussor.",
   "INTENDED USE": "A percussor is a small hammerlike device used by a physician to provide light blows to a\nbody part. A percussor is used as a diagnostic aid during physical examinations",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Photodiode subretinal\nprosthesis system",
   "INTENDED USE": "Designed to provide visual function to a patient with vision loss due to retinal degeneration\nby detecting light, converting it into electrical signals, and relaying them to the retina for\nneural stimulation.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Physical therapy\nultrasound/neuromuscular\nstimulation system",
   "INTENDED USE": "Designed to produce a rhythmic contraction/release of injured muscles to promote the\nremoval of metabolic by-products while applying ultrasound treatments.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pinwheel.",
   "INTENDED USE": "A pinwheel is a device with sharp points on a rotating wheel used for testing pain\nsensation",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Pressure\nalgometer/aesthesiometer,\nelectronic",
   "INTENDED USE": "Intended to measure the sensitivity to pain.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Rheoencephalograph.",
   "INTENDED USE": "A rheoencephalograph is a device used to estimate a patient's cerebral circulation (blood\nflow in the brain) by electrical impedance methods with direct electrical connections to the\nscalp or neck area",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Scalp clip.",
   "INTENDED USE": "A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Scoliosis-treatment electrical\nstimulation system",
   "INTENDED USE": "Intended to apply electrical stimuli to the spinal musculature to produce a force that\nstabilizes or limits the progression of the spinal lateral curvature (i.e., scoliosis).",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Garment,\nProtective, For\nIncontinence",
   "INTENDED USE": "Intended to protect an incontinent patient's garment from\nthe patient's excreta.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Biosanitizer for\nMedical devices",
   "INTENDED USE": "Intended for surface disinfection of medical devices, non\nporous hard-surfaces, medical-equipment, units, as well as\nin-depth cleaning of small surfaces.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Face shield",
   "INTENDED USE": "Intended to protect the wearer's entire face (or part of it)\nfrom hazards such as chemical splashes (in laboratories or\nin industry), or potentially infectious materials\n(in medical and laboratory environments).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Particular\nrespirator,",
   "INTENDED USE": "A disposable medical grade mask (respirator) is a safety\ndevice that covers the nose and mouth and helps protect\nthe wearer from breathing in some hazardous or\npotentially infectious materials (in medical and laboratory\nenvironments).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Radiation\nprotection mitten",
   "INTENDED USE": "A personal protection device that protects the hands of the\noperator and other personnel from unnecessary exposure to\nprimary radiation and scattered radiation associated with\ndiagnosis and therapeutic measures. The mittens are also\ncalled mitts, and protect the thumb and other fingers\nindividually or together.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Radiation\nprotection goggles",
   "INTENDED USE": "A personal protection device that protects the eyes of the\noperator and other personnel from unnecessary exposure to\nprimary radiation and scattered radiation associated with\nmedical/dental procedures for diagnosis and treatment.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Radiation face\nprotector",
   "INTENDED USE": "A transparent or opaque personal protection device that\nprotects the face and eyes of medical personnel and other\npersonnel from unnecessary exposure to primary radiation\nand scattered radiation associated with diagnosis and\ntreatment.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Operator radiation\nprotection\nspectacles",
   "INTENDED USE": "A personal protection device that protects the eyes of the\noperator and other personnel from unnecessary exposure to\nprimary radiation and scattered radiation associated with\ndiagnosis and treatment.The device comes in non-correction\n(non-prescription) glasses and visual acuity correction\n(prescription) glasses.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Latex medical\nexamination glove",
   "INTENDED USE": "Natural rubber gloves used to protect the patient and users\nfrom cross infection during examination, check-up, treatment\nand handling of contaminated medical materials except for\nsurgery.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "chemotherapy spill\nclean-up kit",
   "INTENDED USE": "Designed to safely clean and dispose of Chemotherapy\ndrug spills.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gown/Coveral",
   "INTENDED USE": "Intended to cover full body act as impermeable to blood\nand bodyfluids and ensure a high level of protection from\nbiological/infectious agents",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Medical/Cadaver\nBody Bags",
   "INTENDED USE": "Intended for transporting a human corpse without any\nspread of biohazard/infectious agent.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Abdominal decompression chamber",
   "INTENDED USE": "Non- invasive medical device placed at abdomen to\nalleviate abdominal pain during pregnancy or\ndelivery.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Abdominal decompression chamber pump",
   "INTENDED USE": "A dedicated pump used with hood-like device to\ncontrol and reduce abdominal pressure of a\npregnant women.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Abortion suction system manual aspirator",
   "INTENDED USE": "A non-sterile, manual, syringe-like device to aspirate\nfluid from the uterus for treatment of incomplete\nabortion, first trimester abortion, and/or for\nmenstrual regulation. Aslo used for endometrial\nbiopsy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Birthing bed/table, powered",
   "INTENDED USE": "Bed used during labor and delivery.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiotocograph",
   "INTENDED USE": "A device that records fetal heart rate and uterine\ncontraction simultaneously.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiotocograph transducer",
   "INTENDED USE": "A device that converts birthing contractions to\nelectrical signals and is used together with\ncardiotocograph (CTG) which displays the signals.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiotocography telemetric monitoring\nsystem",
   "INTENDED USE": "An assembly of devices intended to be used to\ncontinuously measure and wirelessly transmit foetal\nheart rate and uterine contraction signals from a\npatient to a monitor.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiotocography telemetric monitoring\nsystem receiver",
   "INTENDED USE": "A part of wireless telemeter system. It receives\nsignals from transmitter that senses fetal heart rate\nand uterine contraction during labor.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cardiotocography telemetric monitoring\nsystem transmitter",
   "INTENDED USE": "It transmits signals related to fetal heart rate and\nuterine contractions to the receiver.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Endocervical specimen collection kit, no\nadditive",
   "INTENDED USE": "sterile devices intended to be used for the collection,\npreservation, and transport of cellular and/or other\nmaterial collected from the endocervix for culture,\nanalysis, and/or other investigation",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Endometrial biopsy curette",
   "INTENDED USE": "surgical instrument used to for the removal of small\namounts of endometrial secretions and/or tissue\nfrom the uterus for biopsy purposes.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Endometrial biopsy kit",
   "INTENDED USE": "for the collection of a tissue sample taken from the\nlining of the uterus (endometrium).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Endometrial cytology brush",
   "INTENDED USE": "A brush used to collect mucosal cell for pathological\ndiagnosis during endoscopic examination.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Fallopian tube biopsy everting-balloon\ncatheter",
   "INTENDED USE": "A sterile device intended to be inserted through a\nhysteroscope to obtain biopsy samples from a\nfallopian tube for cytological examination.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Fallopian tube catheterization kit",
   "INTENDED USE": "A collection of sterile devices for the transuterine\ncatheterization of the fallopian tubes to inject dye or\ncontrast medium for the evaluation of tubal patency.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Fallopian tube insufflator",
   "INTENDED USE": "Active invasive device designed to insufflate the\nFallopian tubes with a gas [typically carbon dioxide\n(CO2)] to maintain tubal patency for a procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Fallopian tube occlusion insert",
   "INTENDED USE": "Contraceptive implantable device implanted into the\nuterine end of the fallopian tubes to function as a\ncontraceptive by obstructing the natural fallopian\ntube passage.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal acoustic stimulator",
   "INTENDED USE": "Uses sound stimuli to assess foetal well-being.This\ndevice is used to evaluate the status of the foetus\nas expressed by, e.g., foetal heart rate changes or\nfoetal acid-base status, in antepartum tests and/or\nduring intrapartum monitoring.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal bladder shunt",
   "INTENDED USE": "A sterile non-bioabsorbable tubular device\nimplanted in the bladder of a foetus with post-\nvesicular obstructive uropathy, to decompress the\nurinary tract for urine to pass from bladder into the\namniotic sac, until the defect can be surgically\nrepaired after birth",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal blood sampler",
   "INTENDED USE": "Invasive device to collect fetal blood through uterine\ncervix.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal cardiac monitor",
   "INTENDED USE": "Active device designed to detect, measure, and\ndisplay foetal heart activity during the perinatal\nperiod",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal pleuro-amniotic catheter",
   "INTENDED USE": "Sterile implantable device used to contineously drain\nfetal pleural effusion to maternal amniotic cavity.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal scalp electrode, clip",
   "INTENDED USE": "Placed directly on the scalp of the fetus in the uterus\nto monitor fetal vital signs.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal stethoscope",
   "INTENDED USE": "Mechanical hearing device used to listen to fetal\nheartbeat.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal vacuum extraction cup, reusable or\nsingle use",
   "INTENDED USE": "A device used to extract the head of the fetus with a\nvaccum cup.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gynaecological operating table,\nelectrohydraulic or electromechanical or\nhydraulic",
   "INTENDED USE": "Acitve device designed to support a patient during\ngynaecological surgical procedures",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Gynaecological scissors, reusable or single\nuse",
   "INTENDED USE": "To cut tissues during a gynaecological surgical\nprocedure; it is not intended for obstetric use.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gynaecological surgical microscope",
   "INTENDED USE": "To improve visualization of anatomical structures via\ntransmitted light during gynaecological surgery (e.g.,\non the fallopian tubes).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Heel stirrup",
   "INTENDED USE": "A device used during a medical/surgical procedure\nto steadily hold a patient's foot (feet) by cradling the\nheel or the whole foot.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Hysteroscopic insufflator",
   "INTENDED USE": "A device that sends the gas into the fallopian tube to\nmaintain the patency of the tubes.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Hysteroscopic irrigation/insufflation system",
   "INTENDED USE": "used during endoscopic procedures of the uterus to\ndistend (expand by pressure) the uterus by filling the\nuterine cavity with a liquid to improve visualization\nand enlarge the surgical field. It also circulates the\nfluid to provide irrigation that will remove\ntissue/debris from the site.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Intrauterine cannula, reusable or single use",
   "INTENDED USE": "To aspirate fluid/material from the uterus for\ntreatment of incomplete abortion, first trimester\nabortion, and/or for menstrual regulation; it may also\nbe intended for endometrial biopsy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Mechanical foetal heart simulator",
   "INTENDED USE": "To imitate a foetal heart (e.g., foetal heart\nultrasound signals) when used in combination with a\nfoetal/maternal multiple physiological parameter\nsimulator in order to test foetal monitoring and\nrecording equipment [e.g., cardiotocograph (CTG)],\ncheck patient cable continuity, or to train healthcare\nproviders.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Menstrual cup, Hevea-latex",
   "INTENDED USE": "Placed in the vagina to collect blood and cellular\ndebris discharges during menstruation and\ndischarges outside of the monthly menses.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Menstrual cup, non-latex, reusable or single\nuse",
   "INTENDED USE": "Placed in the vagina to collect blood and cellular\ndebris discharges during menstruation and\ndischarges outside of the monthly menses.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Menstrual tampon, scented or unscented",
   "INTENDED USE": "Inserted into the vagina to absorb menstrual or\nother vaginal discharge.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Motorized laparoscopic forceps",
   "INTENDED USE": "Active surgical instrument designed for grasping,\nmobilizing, and suturing tissues/vessels under direct\nor endoscopic visualization during a surgical\nprocedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Papanicolaou smear kit or Endometrial\nsampling kit",
   "INTENDED USE": "used to collect and prepare pap smears samples in\na medical institute.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pelvic examination kit",
   "INTENDED USE": "For performing pelvic examination",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pelvimeter",
   "INTENDED USE": "A measuring device used to determine the pelvic\ndimensions.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Pelviscope",
   "INTENDED USE": "An endoscope used for visual examination and\ndiagnosis of pelvis.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Rigid salpingoscope",
   "INTENDED USE": "An endoscope with a rigid inserted portion intended\nfor the visual examination and treatment of the\nfallopian tubes (oviducts)",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Rigid ultrasound laparoscope",
   "INTENDED USE": "An endoscope with a rigid inserted portion,\ncombined with an ultrasound probe, intended for the\nvisual examination, treatment, and ultrasonic\nimaging of the abdominal/retroperitoneal cavity and\nits organs",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Rigid video hysteroscope",
   "INTENDED USE": "Acitve device intended to allow visual examination\nand treatment of the canal of the cervix and the\nuterine cavity (uterus).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Rigid video laparoscope",
   "INTENDED USE": "An endoscope with a rigid inserted portion intended\nfor the visual examination and treatment of the\nabdominal/retroperitoneal cavity and its organs",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Suprapubic needle, surgical, reusable or\nsingle use",
   "INTENDED USE": "Percutaneously puncture the lower abdominal wall\nto provide suprapubic access for surgical repair.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Umbilical ligator",
   "INTENDED USE": "surgical device used for umbilical cord ligation.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Uterine injector",
   "INTENDED USE": "Used to inject liquid, drug, or other substance into\nuterus. It is a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Uterine manipulator cervical\ncup/transilluminator",
   "INTENDED USE": "Allow manipulation of the uterus under suction whilst\npreventing laparoscopic insufflation gas from\nescaping from the cervix (during hysterectomy).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Uterine manipulator, reusable or single use",
   "INTENDED USE": "Surgical instrument designed to mechanically\nmanipulate the position of the uterus during a\ngynaecological intervention",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Viscera retention paddle or Visceral retainer",
   "INTENDED USE": "Used to hold an organ at proper position (i.e.,\nviscera) while the surgeon performs a suturing\nprocedure (typically internal wound closure). It is\nalso implanted into a surgical site temporarily.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Breast transilluminator",
   "INTENDED USE": "Active device transmitted through the female breast\nto visualize translucent tissue for the diagnosis of\ncancer, or other conditions, diseases or\nabnormalities.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Amniotic membrane perforator, reusable",
   "INTENDED USE": "A surgical instrument used to rupture the amniotic\nmembrane to assist in childbirth, without causing\ninjury to the mother or foetus",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Amniotome, reusable",
   "INTENDED USE": "A surgical instrument used to rupture the amniotic\nmembrane to assist in childbirth, without causing\ninjury to the mother or foetus",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Birthing/delivery kit",
   "INTENDED USE": "A collection of sterile devices designed for the\nprocedures associated with the birthing and delivery\nof a newborn",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Bladder-supporting pessary",
   "INTENDED USE": "inserted into the vagina to facilitate management of\nfemale urinary incontinence and/or to reduce\nbladder prolapse.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Catheter-tip transducer, pressure",
   "INTENDED USE": "A device intended to be incorporated into the distal\nend of a catheter (not included) to measure\npressure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal Doppler system",
   "INTENDED USE": "Active non invasive device to detect foetal heart\nbeats using ultrasound/Doppler technology.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Foetal Doppler system probe",
   "INTENDED USE": "placed on the surface of a pregnant woman's\nabdomen to detect foetal heart beats using\nultrasonic/Doppler technology.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Adaptometer",
   "INTENDED USE": "An ophthalmic device intended to measure the time required for retinal\nadaptation and the minimum light threshold.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Amsler grid",
   "INTENDED USE": "An ophthalmic device intended to rapidly detect central and paracentral\nirregularities in the visual field.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Anomaloscope",
   "INTENDED USE": "A ophthalmic instrument used to test a patient for abnormal red/green\ncolour vision by differentiating the red/green colour vision defects.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Aqueous/vitreous humour\nreplacement medium kit",
   "INTENDED USE": "A collection of sterile devices, including a fluid or semifluid substance,\nused in combination to replace the fluid of the eye.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Automated\nlensmeter(Dioptometer)",
   "INTENDED USE": "An ophthalmic instrument designed to measure the focusing power\n(dioptric power) and other optical characteristics of a spectacle lens,\ncontact lens, or prism.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Bagolini lens",
   "INTENDED USE": "An ophthalmic plane lens, intended to determine\nharmonious/anomalous retinal correspondence.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Binocular vision test unit",
   "INTENDED USE": "An ophthalmic device for binocular vision testing.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Blepharoplasty scissors",
   "INTENDED USE": "A hand-held, manual, ophthalmic surgical instrument intended to be\nused to cut eyelid tissue during plastic surgery of the eyelids\n(blepharoplasty).",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Capsular bag anchor",
   "INTENDED USE": "A device intended to be permanently implanted in the posterior\nchamber of the eye for correction and fixation of a subluxated capsular\nbag, typically in association with in-the-bag intraocular lens (IOL)\nimplantation.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Corneal burr, abrasion",
   "INTENDED USE": "A device designed for abrasion of the cornea to polish corneal scratches\nand/or the pterygium bed after surgical removal, and/or for abrasion of\nlid margin lesions.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Corneal burr, rust ring removal",
   "INTENDED USE": "A device designed for gentle removal of rust stains (rust rings) from the\ncornea after the extraction of a ferrous foreign object.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Corneal epithelium perforator",
   "INTENDED USE": "Intended to create a number of small perforations in the epithelial layer\nof the cornea through which riboflavin can pass into the cornea during\ncorneal collagen crosslinking, to treat corneal ectasia (typically\nkeratoconus).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Corneal epithelium trephine",
   "INTENDED USE": "Intended to create a circular cut through the epithelial layer of the\ncornea to create an epithelial flap intended to be folded back during\nlaser assisted epithelial keratomileusis (LASEK) surgery, after which the\nflap is replaced.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Corneal inlay, aperture\nreducing",
   "INTENDED USE": "A implantable device inserted into the natural cornea to treat\npresbyopia based on aperture reduction.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Corneal inlay, cornea-\nreshaping",
   "INTENDED USE": "A implantable device inserted into the natural cornea to treat refractive\nerrors by reshaping the cornea.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Corneal light shield",
   "INTENDED USE": "A device, typically made of a non-abrasive fluid-absorbing material that\nis placed on the surface of the cornea to shield the retina from\nexcessive illumination during an ophthalmic procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Corneal marker",
   "INTENDED USE": "Amanual instrument intended to be used to imprint, indent, and/or\nincise corneal tissue prior to an ophthalmic surgical procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Corneal resection holder",
   "INTENDED USE": "A device designed to hold donated corneal tissue so that it can be\nresected in preparation for transplantation.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Exophthalmometer",
   "INTENDED USE": "An ophthalmic instrument used to measure the degree of\nexophthalmos.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Eye cup",
   "INTENDED USE": "A receptacle designed to fit around the eye socket and which is filled\nwith warm water or an eyewash solution and placed over the eye to\nallow the liquid to wash the affected eye.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Eye heat therapy pack",
   "INTENDED USE": "A device intended to be placed over closed eyes to apply heat for the\ntreatment of meibomian gland dysfunction (MGD), dry eye syndromes,\nblepharitis and other related ocular conditions.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Eye irrigation shield",
   "INTENDED USE": "A device intended to be used with an eye irrigation kit/system to direct\nirrigation solution to the surface of the eye and allow the solution to\ngently lavage the surface of the eye.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Eye muscle clamp",
   "INTENDED USE": "An hand-held manual ophthalmic surgical instrument designed to\natraumatically grasp and hold the extraocular muscles (EOM) during an\nophthalmic surgical intervention.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Eye muscle sleeve",
   "INTENDED USE": "An implantable device made from synthetic materials that is used to\nencase or isolate an ocular muscle.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Eye pad",
   "INTENDED USE": "A sterile, cushion-like device intended to protect the eye or to absorb\neye secretions.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Eye spud",
   "INTENDED USE": "A hand-held, manual, ophthalmic surgical instrument intended to be\nused to remove a foreign body/object embedded in or adhering to the\nsurface of the eye globe.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Eye valve",
   "INTENDED USE": "An implantable device designed to regulate the flow of fluid between\nthe anterior chamber and the space around the conjunctiva of the eye\nby allowing flow when the pressure in the chamber is above a pre-set\nvalue.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Fresnel prism",
   "INTENDED USE": "A device intended to be applied to spectacle lenses to give a prismatic\neffect typically to manage strabismus or other eye muscle dysfunction.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Fundus-imaging ophthalmic\ndiode laser system",
   "INTENDED USE": "Intended for: ocular laser treatment procedures, including coagulation\nof abnormal retinal vasculature; and capturing real-time digital images\nof the anterior/posterior eye segments created using colour, fluorescein\nangiography and infrared imaging, for diagnosis/treatment planning.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Fundus-imaging ophthalmic\nsolid-state laser system",
   "INTENDED USE": "Intended to coagulate abnormal vascular tissue in the retina and for\nother ocular photocoagulation procedures.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Glaucoma supraciliary implant",
   "INTENDED USE": "A non-bioabsorbable synthetic polymer device designed to be\nimplanted in the supraciliary space (between the ciliary muscle/body\nand the sclera) for the restoration of aqueous humour outflow and\nsubsequent reduction of intraocular pressure as part of treatment for\nopen angle glaucoma.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Glaucoma therapy ultrasound\nsystem",
   "INTENDED USE": "A system designed to transduce radio-frequency (RF) electrical energy\nfrom a generator into ultrasound energy, for the extracorporeal\napplication of high intensity focused ultrasound (HIFU) to the eye, to\ndecrease aqueous humour production and reduce intraocular pressure\n(IOP)",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Haidinger brush imager",
   "INTENDED USE": "An ophthalmic device designed to produce an image which facilitates\nhis/her visual function evaluation, particularly the macular integrity.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Hand-held campimeter",
   "INTENDED USE": "A portable, hand-held device intended for assessing the central 30o\nvisual field.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Lacrimal tube",
   "INTENDED USE": "A implantable, single-lumen tube intended to provide tear drainage\nfrom the front surface of the eye, and also to facilitate saline solution\nirrigation to a paranasal sinus to manage chronic rhinosinusitis.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Lens spoon",
   "INTENDED USE": "A hand-held ophthalmic surgical instrument used in ophthalmic surgery\nto manipulate/remove the lens of the eye.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Maddox trial lens",
   "INTENDED USE": "A special ophthalmic trial lens in the form of a rod or series of rods\n(grooves/cylinders) that changes the size, shape, and colour of an image\nto dissociate the eyes in the evaluation of eye muscle dysfunction.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Mirror-prism spectacles",
   "INTENDED USE": "An optical device intended to enable the patient to see over the top of\ntheir head enabling them to look forward in the direction their head is\npointing.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Nystagmus inducing\noptokinetic drum",
   "INTENDED USE": "An ophthalmic device intended to elicit nystagmus.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Nystagmus inducing tape",
   "INTENDED USE": "An ophthalmic device intended to be moved across a patient's field of\nvision to elicit optokinetic nystagmus and to test for blindness.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ocular occluder",
   "INTENDED USE": "An hand-operated ophthalmic device typically used by an\noptician/optometrist to temporarily prevent or attenuate (occlude) the\npassage of light (vision) to one eye, during examination and testing of a\npatient's eyesight in the opposite eye.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ophthalmic calliper",
   "INTENDED USE": "A hand-held manual ophthalmic measuring instrument consisting of two\nlegs hinged at one end and designed to measure the diameter, length,\nangles, and thicknesses of the eye.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ophthalmic operating table\ntop",
   "INTENDED USE": "A component of a modular operating table intended to provide support\nfor and stabilization of the head of the patient (typically includes a\nheadrest) and to help provide optimal access for the surgeon(s) during\nthe intervention (e.g., by having a small-width table top and therefore a\nshorter stretch distance for the surgeon).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ophthalmic soft-tissue surgical\nforceps",
   "INTENDED USE": "A hand-held manual instrument designed to grasp and manipulate\nintraocular tissues during ophthalmic surgery (e.g., anterior segment\nsurgery, vitreo-retinal procedures, iridectomy, capsulorhexis).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ophthalmic surgical device\nhandling forceps",
   "INTENDED USE": "A hand-held manual surgical instrument with blades designed to grasp\nand manipulate a nonimplantable invasive ophthalmic surgical device\n(e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic\nsuturing.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ophthalmic suture scissors",
   "INTENDED USE": "A hand-held, manual, ophthalmic surgical instrument intended to be\nused to cut suture during eye surgery.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ophthalmic tonometer",
   "INTENDED USE": "An ophthalmic, measuring instrument designed for determining the\nintraocular pressure (IOP).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ophthalmic ultrasound\nimaging system",
   "INTENDED USE": "An assembly of devices designed for ophthalmic ultrasound imaging\nprocedures.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ophthalmodiastimeter",
   "INTENDED USE": "An ophthalmic instrument for determining the proper distance at which\nto place prescription lenses for the two eyes.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ophthalmoleukoscope",
   "INTENDED USE": "An ophthalmic device intended to be used for testing colour perception\nby means of colours produced by polarized light.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ophthalmoscope",
   "INTENDED USE": "An ophthalmic instrument designed to examine the interior of the eye\nallowing the examiner to clearly see the details of the retina and other\nstructures/media.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Polatest",
   "INTENDED USE": "An ophthalmic device used for evaluating hidden (latent) squinting, i.e.,\nwhen the patient is not aware of the condition, and also when it cannot\nbe seen.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ptosis crutch",
   "INTENDED USE": "A device that is attachment to an ophthalmic spectacle frame to prop\nopen the upper eyelid in cases of ptosis.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ptosis sling",
   "INTENDED USE": "A sterile implantable device intended for the surgical correction of\nptosis.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Pupillograph",
   "INTENDED USE": "A graphic recorder used for recording the response of the pupil to\nreflected light. It is used for ophthalmic diagnostic purposes.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Pupillometer",
   "INTENDED USE": "An ophthalmic instrument used for measuring the width or diameter of\nthe pupil.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Recumbent spectacles",
   "INTENDED USE": "An optical/ophthalmic device that consists of prismatic lenses that is\nworn in front of the user's eyes to angle the field of vision enabling the\nuser to read or watch television whilst lying in a supine position.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Retinal tack",
   "INTENDED USE": "A non-bioabsorbable, implantable device designed to permanently fix a\ndetached retina to the underlying retinal pigment epithelium (RPE)\nduring ophthalmic surgery.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Scleral buckling device",
   "INTENDED USE": "A device intended to be implanted on the sclera to compress the eye\n(scleral buckling) for the surgical treatment of retinal detachment.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Scleral expansion implant",
   "INTENDED USE": "A device designed for implantation in the sclera to produce expansion\nby altering the position of the underlying ciliary muscle.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Scleral marker",
   "INTENDED USE": "Amanual instrument used to indent or imprint the surface of the sclera\nduring an ophthalmic surgical or perioperative procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Tachistoscope",
   "INTENDED USE": "An ophthalmic device designed to flash words or images at different\nspeeds, for the purposes of ophthalmic diagnostic testing.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Tinted spectacle lens",
   "INTENDED USE": "An ophthalmic device used to correct the refractive errors of that\npatient's eyesight and to attenuate light radiation by absorption,\nreflection, or polarization.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Tinted spectacles",
   "INTENDED USE": "An optical device that contains a pair of tinted spectacle lenses that are\nworn in front of the user's eyes to correct the refractive errors of that\npatient's eyesight and to attenuate light radiation by absorption,\nreflection, or polarization.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Trial lens",
   "INTENDED USE": "An individual ophthalmic lens from a trial lens set.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Trial lens clip",
   "INTENDED USE": "A device used to hold prisms, spheres, cylinders, or occluders on a trial\nlens frame or set of spectacles during vision testing.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Trial lens frame",
   "INTENDED USE": "A device used in ophthalmic work for placing, holding, and exchanging\ntrial lenses in front of the eyes of the patient during a sight-testing\nprocedure.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Trial lens set",
   "INTENDED USE": "A set of ophthalmic trial lenses of various dioptric powers intended for\nvision testing to determine the required refraction.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Ultrasound pachymeter",
   "INTENDED USE": "An ophthalmic device designed to use ultrasound to measure the\nthickness of the cornea, and may in addition be designed to measure\naxial length and anterior chamber depth.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Visual chart",
   "INTENDED USE": "An ophthalmic chart (Snellen chart) used in testing visual .",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Visual light box",
   "INTENDED USE": "A light viewing box that uses a translucent version of the ophthalmic\nchart (Snellen chart) used for testing visual acuity.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Visual projector",
   "INTENDED USE": "An ophthalmic device intended to project an image on a screen to test\nvisual acuity .",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Acupressure calf\nband",
   "INTENDED USE": "Intende to wear around the calf to apply pressure to an acupressure\npoint to relieve low back pain, including sciatica and piriformis\nsyndrome.A Non powered belt like device.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Arthritis TENS\nsystem",
   "INTENDED USE": "Intended to be used as adjunctive therapy in reducing the level of\npain and stiffness associated with rheumatoid arthritis or\nosteoarthritis by electrically stimulating peripheral nerves across\nthe skin (transcutaneously).",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Back pulldown\nexerciser",
   "INTENDED USE": "Intended to strengthen the muscles of the back (especially the\nlatissimus dorsi) through a repetitive pulldown motion performed\nwith the arms against the force of a weight.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Back row\nexerciser",
   "INTENDED USE": "intended to strengthen the muscles of the back through a repetitive\nrowing motion (as in rowing a boat with oars) performed with the\narms against the force of a weight.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Back/leg/chest\ndynamometer,\nelectronic",
   "INTENDED USE": "Powered device intended to assess neuromuscular function by\nmeasuring the force or power exerted by the back, chest, and/or leg\nmuscles during flexion.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Back/leg/chest\ndynamometer,\nmechanical",
   "INTENDED USE": "Non powered device intended to assess neuromuscular function by\nmeasuring the force or power exerted by the back, chest, and/or leg\nmuscles during flexion.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Balance ball\nexerciser",
   "INTENDED USE": "Intended to be used as an unstable surface on which to perform\nexercise to improve balance and posture.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Circulating-fluid\nthermal therapy\nsystem",
   "INTENDED USE": "Intended to be used to pump heated and/or cooled fluid (e.g.,\nwater) through externally applied packs for localized hot and/or cold\ntherapy to help treat a variety of adverse conditions resulting from\nmusculoskeletal injury (e.g., pain, swelling, inflammation).",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Cold compression\ntherapy cervical\nspine collar",
   "INTENDED USE": "Intended to facilitate, through cooling and compression, the\ntreatment of a variety of conditions resulting from injury/surgery to\nthe neck region (e.g., inflammation, stiffness, whiplash).",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Cold/cool therapy\ngel",
   "INTENDED USE": "intended for localized topical skin application to provide a cooling\neffect for underlying muscles/joints to reduce pain and swelling.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Cold-air therapy\nunit",
   "INTENDED USE": "Intended to reduce localized pain/inflammation, and/or to reduce\nthermal skin damage by applying cold stream of air during\ndermatological laser treatments.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Core-body\nmechanical\nweight exerciser",
   "INTENDED USE": "Intended to enable a patient with a lumbar spine injury to perform\ncontrolled extension, contraction, and/or twisting movements of the\nlumbar/thoracic spine back region and the abdomen, for testing and\nrehabilitation.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Deep-tissue\nelectromagnetic\nstimulation\nsystem",
   "INTENDED USE": "Intended to apply an electromagnetic (EM) field to body tissues to:\n1) treat musculoskeletal disorders (e.g., osteoarthritis,\nosteoporosis); 2) treat body pain (musculoskeletal, postsurgical);\nand/or 3) help facilitate soft and hard tissue wound/injury healing,\nwith no production of a therapeutic deep heat.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Electric massager",
   "INTENDED USE": "Intended for respiratory therapy or physiotherapy (e.g., help reduce\nmuscular tension, arthritic pain or joint mobility) in the home and/or\nhealthcare facility.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Hydrotherapy\ntreadmill",
   "INTENDED USE": "Powered device intended for use in partially immersed in water,\ne.g., in a hydrotherapy tank, to provide additional resistance to the\ntreadmill walking exercise without increasing the impact and/or\nstress on the patient's joints.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Interferential\nelectrical\nstimulation\nsystem",
   "INTENDED USE": "Intended to stimulate peripheral nerves through the transcutaneous\napplication of two currents of slightly different frequencies that\ncross-over/interfere, producing a beating frequency at the treatment\npoint.",
   "RISK BASED CLASSIFICATION": "Class C"
 },
 {
   "MEDICAL DEVICE NAME": "Manual\ngoniometer",
   "INTENDED USE": "Non powered device intended to be used in a clinical setting to\nmeasure the range of motion of the limb of a patient by measuring\nthe angle of movement achieved at the joint.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Medium-wave\ndiathermy\ntreatment system",
   "INTENDED USE": "Intended to produce a therapeutic deep heat within specific\nvolumes of the body through the transcutaneous transmission of\nelectromagnetic (EM) energy in the radio-frequency (RF) bands of\n0.5 megahertz (MHz) to 1 MHz.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Microwave\ndiathermy\ntreatment system",
   "INTENDED USE": "Intended to produce a therapeutic heat 1 to 2 cm below the skin\nwithin specific volumes of the body through the transcutaneous\ntransmission of high frequency electromagnetic (EM) energy,\ntypically 2,450 megahertz (MHz) [microwave], to promote tissue\nhealing and pain relief.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Musculoskeletal\ninfrared\nphototherapy unit,",
   "INTENDED USE": "Intended to provide a source of infrared (IR) heat for localized\ntreatment of musculoskeletal pain/injury (e.g., muscle pain, sports\ninjury, rheumatism) and to improve blood circulation in the treated\nareas to facilitate healing.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Musculoskeletal\nintense\ntherapeutic\nultrasound\nsystem",
   "INTENDED USE": "Intended to produce and deliver intense therapeutic ultrasound\n(ITU) waves through the skin to create ablative lesions in\nsubcutaneous soft tissues (e.g., muscles, tendons).",
   "RISK BASED CLASSIFICATION": "Class C"
 },
 {
   "MEDICAL DEVICE NAME": "Standard\ntreadmill,\npowered",
   "INTENDED USE": "Electrically powered unit intended to facilitate in-place walking,\njogging, or running to promote muscle redevelopment, to restore\nmotion to joints, and to promote weight loss and cardiovascular\nfitness.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Telemetric\ndiagnostic\nspirometer",
   "INTENDED USE": "It is a Battery powered portable device Intended to measure several\nor all respiratory-gas volume and flow parameters needed to\nevaluate basic pulmonary function [e.g., vital capacity (VC), peak\nexpiratory flow (PEF), forced expiratory volume (FEV), and forced\nexpiratory flow (FEF)], and to transmit the pulmonary function data\nvia a communication device to a healthcare professional(s) at a\nremote server.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Therapeutic\nnuclear magnetic\nresonance\nsystem",
   "INTENDED USE": "Intended to influence cellular metabolism using nuclear magnetic\nresonance (NMR) for the treatment of degenerate and pathological\nchanges to the movement/support profiles of a patient's body, in\nparticular diseased skeletal joints, bones, and surrounding muscle\ntissue (e.g., cervical and lumbar spine, shoulders, elbows, hands,\nhips, knees, feet).",
   "RISK BASED CLASSIFICATION": "Class C"
 },
 {
   "MEDICAL DEVICE NAME": "Wall bars",
   "INTENDED USE": "A device that is permanently fixed to the wall intended for training\nand rehabilitation to regain and/or improve body movement and\nbalance and/or for strengthening the limbs and the trunk of the\nbody.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Ankle\ncontinuous\npassive\nmotion\nexerciser",
   "INTENDED USE": "Electrical device intended to continuously move the ankle joint\n(e.g., flexion, inversion/eversion) without patient assistance during\ncontinuous passive motion (CPM) exercise therapy usually\nfollowing surgery or trauma to the joint.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Ankle/foot\northosis",
   "INTENDED USE": "Intended to encompass the ankle joint, or the ankle and foot, to\nsupport, align, prevent, or correct orthopaedic deformities/injuries\nor to improve function of the ankle and/or foot; it may also be\nintended to offload and redistribute foot pressures that affect pedal\ncirculation to improve blood flow and help heal diabetic foot ulcers\nor postsurgical wounds.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Balance\nboard",
   "INTENDED USE": "Intended to train patient with difficulties in balance (e.g., a\nparaplegic or a stroke victim) walks for balance training.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Bed traction\nframe",
   "INTENDED USE": "Intended to treat patients with fractures and other orthopaedic\ndisorders (e.g., of the lower or cervical spine, hip).",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Body arch\ntraction table",
   "INTENDED USE": "Intended to support the body of a patient and provide traction for\nthe back muscles and spine by flexing the patient into a reverse\nsupine body arch.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Cranial\northosis",
   "INTENDED USE": "Intended to be worn on the head of an infant with an abnormal\nhead shape (e.g., due to plagiocephaly, brachycephaly,\nscaphocephaly), or after craniosynostosis repair surgery, to apply\npressure to the cranium and improve cranial symmetry/shape\nduring growth over a period of months.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Elbow\northosis",
   "INTENDED USE": "Intended to encompass the elbow joint to support, align, prevent,\nor correct deformities/injuries or to improve function of the elbow.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Finger\northosis",
   "INTENDED USE": "Intended to encompass the whole or part of the finger to support,\nalign, prevent, or correct deformities/injuries or to improve function\nof the finger.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Flotation\ntherapy bed,\nadult",
   "INTENDED USE": "Intended to minimize pressure points on a patient's body by\nproviding contact with as much of the body surface as possible,\ntypically through a mattress that contains a large volume of\nconstantly moving media, e.g., water, air, or mud that lifts the\npatient to simulate a floating effect.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Flotation\ntherapy bed,\nneonatal",
   "INTENDED USE": "Intended to minimize pressure points on neonatal patient's body by\nproviding contact with as much of the body surface as possible,\ntypically through a mattress that contains a large volume of\nconstantly moving media, e.g., water, air, or mud that lifts the\npatient to simulate a floating effect.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Foot orthosis",
   "INTENDED USE": "Intended to encompass the whole or part of the foot, or designed\nas a plantar insert, and intended to provide rigid or semi-rigid\ncorrection of the foot for persons with orthopaedic\ndeformities/injuries of the feet",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Kinetic bed",
   "INTENDED USE": "Intend to enable continuous change of the patient's lying position,\ne.g., it can tilt the entire bed mattress support system (this includes\nthe mattress, the framework that supports the mattress, and the\nbedding) lengthways, sideways or to a near vertical tilt.",
   "RISK BASED CLASSIFICATION": "NA"
 },
 {
   "MEDICAL DEVICE NAME": "Knee\nimmobilizer",
   "INTENDED USE": "Intended to temporarily render the knee immovable, either\npreoperatively or following injury or arthroscopy.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Neuro-\ncontrolled\nambulation\nexoskeleton",
   "INTENDED USE": "Intended to assist a patient with a walking disability (neurogenic,\nmuscular, or osseous in origin) regain lost motor function by\ntransmission of the patient<6E>s residual nerve function, via cutaneous\nelectrodes, to the device motor assembly.",
   "RISK BASED CLASSIFICATION": "Class C"
 },
 {
   "MEDICAL DEVICE NAME": "Orthopaedic\nbed",
   "INTENDED USE": "Intended to provide support for skeletal traction to stabilize fracture\nsites.",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Paediatric\ndorsiflexion\nslant board",
   "INTENDED USE": "Intended to be used in the treatment of various medical conditions\n(e.g., congenital, neurological, post-traumatic) in paediatrics, where\ntendon tightness and muscle contracture affect the ability to\ndorsiflex the foot, possibly leading to an abnormal gait",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Parapodium\nwalking frame",
   "INTENDED USE": "Intended to encompasses and provide support for the body of a\npatient who is unable to stand unassisted to help them move (walk)\nby changing their centre of gravity (COG).",
   "RISK BASED CLASSIFICATION": "Class A"
 },
 {
   "MEDICAL DEVICE NAME": "Physical\ntherapy\nmassager",
   "INTENDED USE": "Electrically powered device intended to provide therapeutic\nmassage to a larger area than hand-held massaging devices.",
   "RISK BASED CLASSIFICATION": "Class B"
 },
 {
   "MEDICAL DEVICE NAME": "Scintillation\n(gamma) camera",
   "INTENDED USE": "A scintillation (gamma) camera is a device intended to image the distribution of\nradionuclides in the body by means of a photon radiation detector.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Positron camera",
   "INTENDED USE": "A positron camera is a device intended to image the distribution of positron-\nemitting radionuclides in the body.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Nuclear whole\nbody counter",
   "INTENDED USE": "A nuclear whole body counter is a device intended to measure the amount of\nradionuclides in the entire body.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Bone densitometer",
   "INTENDED USE": "A bone densitometer is a device intended for medical purposes to measure bone\ndensity and mineral content by x-ray or gamma ray transmission measurements\nthrough the bone and adjacent tissues.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Bone sonometer",
   "INTENDED USE": "A bone sonometer is a device that transmits ultrasound energy into the human body\nto measure acoustic properties of bone that indicate overall bone health and\nfracture risk.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Emission computed\ntomography\nsystem.",
   "INTENDED USE": "An emission computed tomography system is a device intended to detect the\nlocation and distribution of gamma ray- and positron-emitting radionuclides in the\nbody and produce cross-sectional images through computer reconstruction of the\ndata",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Radionuclide\nrebreathing system",
   "INTENDED USE": "A radionuclide rebreathing system is a device intended to be used to contain a\ngaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be\nrespired by the patient during nuclear medicine ventilatory tests (testing process of\nexchange between the lungs and the atmosphere).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Nuclear sealed\ncalibration source",
   "INTENDED USE": "A nuclear sealed calibration source is a device that consists of an encapsulated\nreference radionuclide intended for calibration of medical nuclear radiation\ndetectors.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Nuclear\nelectrocardiograph\nsynchronizer",
   "INTENDED USE": "A nuclear electrocardiograph synchronizer is a device intended for use in nuclear\nradiology to relate the time of image formation to the cardiac cycle during the\nproduction of dynamic cardiac images",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Radionuclide test\npattern phantom",
   "INTENDED USE": "A radionuclide test pattern phantom is a device that consists of an arrangement of\nradiopaque or radioactive material sealed in a solid pattern intended to serve as a\ntest for a performance characteristic of a nuclear medicine imaging device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Nonfetal ultrasonic\nmonitor",
   "INTENDED USE": "A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency\nsound wave into body tissue other than a fetus to determine frequency changes\n(doppler shift) in the reflected wave and is intended for use in the investigation of\nnonfetal blood flow and other nonfetal body tissues in motion",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ultrasonic pulsed\ndoppler imaging\nsystem",
   "INTENDED USE": "An ultrasonic pulsed doppler imaging system is a device that combines the features\nof continuous wave doppler-effect technology with pulsed-echo effect technology\nand is intended to determine stationary body tissue characteristics, such as depth or\nlocation of tissue interfaces or dynamic tissue characteristics such as velocity of\nblood or tissue motion.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Non-image-\nintensified\nfluoroscopic x-ray\nsystem",
   "INTENDED USE": "A non-image-intensified fluoroscopic x-ray system is a device intended to be used to\nvisualize anatomical structures by using a fluorescent screen to convert a pattern of\nx-radiation into a visible image.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Spot-film device",
   "INTENDED USE": "A spot-film device is an electromechanical component of a fluoroscopic x-ray system\nthat is intended to be used for medical purposes to position a radiographic film\ncassette to obtain radiographs during fluoroscopy",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Diagnostic x-ray\nhigh voltage\ngenerator",
   "INTENDED USE": "A diagnostic x-ray high voltage generator is a device that is intended to supply and\ncontrol the electrical energy applied to a diagnostic x-ray tube for medical purposes.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Mammographic x-\nray system",
   "INTENDED USE": "A mammographic x-ray system is a device intended to be used to produce\nradiographs of the breast",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Full-field digital\nmammography\nsystem",
   "INTENDED USE": "A full-field digital mammography system is a device intended to produce planar\ndigital x-ray images of the entire breast",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Photofluorographic\nx-ray system",
   "INTENDED USE": "A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit\nand a camera intended to be used to produce, then photograph, a fluoroscopic\nimage of the body",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Diagnostic x-ray\ntube housing\nassembly.",
   "INTENDED USE": "A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a\nradiation-shielded housing that is intended for diagnostic purposes.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Diagnostic x-ray\ntube mount",
   "INTENDED USE": "A diagnostic x-ray tube mount is a device intended to support and to position the\ndiagnostic x-ray tube housing assembly for a medical radiographic procedure.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Pneumoencephalo\ngraphic chair",
   "INTENDED USE": "A pneumoencephalographic chair is a chair intended to support and position a\npatient during pneumoencephalography (x-ray imaging of the brain).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Radiographic grid",
   "INTENDED USE": "A radiographic grid is a device that consists of alternating radiolucent and\nradiopaque strips intended to be placed between the patient and the image\nreceptor to reduce the amount of scattered radiation reaching the image receptor",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Radiographic head\nholder",
   "INTENDED USE": "A radiographic head holder is a device intended to position the patient's head\nduring a radiographic procedure.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Radiologic quality\nassurance\ninstrument",
   "INTENDED USE": "A radiologic quality assurance instrument is a device intended for medical\npurposes to measure a physical characteristic associated with another\nradiologic device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Radiographic\nanthropomorphic\nphantom",
   "INTENDED USE": "A radiographic anthropomorphic phantom is a device intended for medical purposes\nto simulate a human body for positioning radiographic equipment.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Radiographic\nintensifying screen",
   "INTENDED USE": "A radiographic intensifying screen is a device that is a thin radiolucent sheet coated\nwith a luminescent material that transforms incident x-ray photons into visible light\nand intended for medical purposes to expose radiographic film.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Radiographic\nECG/respirator\nsynchronizer",
   "INTENDED USE": "A radiographic ECG/respirator synchronizer is a device intended to be used to\ncoordinate an x-ray film exposure with the signal from an electrocardiograph (ECG)\nor respirator at a predetermined phase of the cardiac or respiratory cycle.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Radiologic table",
   "INTENDED USE": "A radiologic table is a device intended for medical purposes to support a patient\nduring radiologic procedures. The table may be fixed or tilting and may be\nelectrically powered.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Medical image\nanalyzer",
   "INTENDED USE": "Medical image analyzers, including computer-assisted/aided detection (CADe)\ndevices for mammography breast cancer, ultrasound breast lesions, radiograph lung\nnodules, and radiograph dental caries detection, is a prescription device that is\nintended to identify, mark, highlight, or in any other manner direct the clinicians'\nattention to portions of a radiology image that may reveal abnormalities during\ninterpretation of patient radiology images by the clinicians. This device incorporates\npattern recognition and data analysis capabilities and operates on previously\nacquired medical images. This device is not intended to replace the review by a\nqualified radiologist, and is not intended to be used for triage, or to recommend\ndiagnosis.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Radiological\ncomputer aided\ntriage and\nnotification\nsoftware",
   "INTENDED USE": "Radiological computer aided triage and notification software is an image processing\nprescription device intended to aid in prioritization and triage of radiological\nmedical images. The device notifies a designated list of clinicians of the availability\nof time sensitive radiological medical images for review based on computer aided\nimage analysis of those images performed by the device.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Full-body MRI\nsystem, permanent\nmagnet",
   "INTENDED USE": "A general-purpose magnetic resonance imaging (MRI) system designed to scan any\ntargeted area of the body. It includes a permanent magnet assembly.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Full-body MRI\nsystem, resistive\nmagnet",
   "INTENDED USE": "A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to\nscan any targeted area of the body (full-body imaging). It includes a resistive magnet\nassembly.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Full-body MRI\nsystem,\nsuperconducting\nmagnet",
   "INTENDED USE": "A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to\nscan any targeted area of the body (full-body imaging). This system includes a\nsuperconducting magnet assembly.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible ultrasound\nbronchoscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual examination\nand treatment of the trachea, bronchi, and lungs. It is inserted through the mouth\nor nose during bronchoscopy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Bladder ultrasound\nimaging transducer",
   "INTENDED USE": "An ultrasound imaging transducer assembly specifically designed to be positioned\nwithin the bladder either manually or under endoscopic guidance that steers,\nfocuses, and detects the ultrasound beam and resulting echoes either mechanically\nor electronically.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Blood flowmeter\ncatheter, Doppler",
   "INTENDED USE": "A flexible tube intended to be inserted into the lumen of a blood vessel to\ndetermine blood-flow velocity by measuring the ultrasonic frequency shift between\ntransmitted and reflected signals (Doppler principle).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "General-purpose\nultrasound imaging\nsystem",
   "INTENDED USE": "A stationary or mobile (e.g., on wheels) assembly of devices designed to collect,\ndisplay, and analyse ultrasound images during a variety of extracorporeal and/or\nintracorporeal (endosonography or endoscopic) ultrasound imaging procedures\n(e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical\nimaging).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Organ bag.",
   "INTENDED USE": "An organ bag is a device that is a flexible plastic bag\nintended to be used as a temporary receptacle for an\norgan during surgical procedures to prevent moisture\nloss.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Polymer Ligating\nClips",
   "INTENDED USE": "\"Hem-o-lok ligating clips are intended for use in\nprocedures involving ligation of vessels or tissue\nstructures. . Hem-o-lok ligating clips are\ncontraindicated for use in ligating the renal artery\nduring laparoscopic donor nephrectomies.\"",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Surgical camera\nand accessories.",
   "INTENDED USE": "A surgical camera and accessories is a device\nintended to be used to record operative procedures.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Suture retention\ndevice",
   "INTENDED USE": "A suture retention device is a device, such as a\nretention bridge, a surgical button, or a suture bolster,\nintended to aid wound healing by distributing suture\ntension over a larger area in the patient",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Ultraviolet lamp\nfor dermatologic\ndisorders.",
   "INTENDED USE": "An ultraviolet lamp for dermatologic disorders is a\ndevice (including a fixture) intended to provide\nultraviolet radiation of the body to photoactivate a drug\nin the treatment of a dermatologic disorder if the\nlabeling of the drug intended for use with the device\nbears adequate directions for the device's use with\nthat drug.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Wound\nautofluorescence\nimaging device",
   "INTENDED USE": "A wound autofluorescence imaging device is a tool to\nview autofluorescence images from skin wounds that\nare exposed to an excitation light. The device is not\nintended to provide quantitative or diagnostic\ninformation.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Dermal dilator",
   "INTENDED USE": "A device to be temporarily implanted subcutaneously\nto dilate the surrounding skin. Usually, a balloon is\nimplanted subcutaneously where solutions including\nsaline solution are infused.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Dermatome",
   "INTENDED USE": "A surgical knife used to harvest the skin for grafting.\nEither manual or electric-powered.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dermatome skin\napproximation\ntape",
   "INTENDED USE": "A tape that comes in various sizes with adhesive on\nboth sides. It is attached onto a skin graft knife to\ncollect a skin graft tissue. This device is for single-use.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Drape adhesive.",
   "INTENDED USE": "A drape adhesive is a device intended to be placed\non the skin to attach a surgical drape.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Electrically-\npowered trephine\nsystem",
   "INTENDED USE": "A rotary surgical device consisting of a motor (an\nengine) and a cylindrical or trephine insertion portion.\nThe blade is beveled on one side. It is used for\nremoval of the intervertebral disc, other hard soft\ntissues, or soft tissues.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Electrosurgical\ncutting and\ncoagulation device\nand accessories",
   "INTENDED USE": "Electrosurgical cutting and coagulation device and\naccessories is a device intended to remove tissue and\ncontrol bleeding by use of high-frequency electrical\ncurrent.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Gas-powered\ntrephine system",
   "INTENDED USE": "A rotary surgical device consisting of a motor (an\nengine) and a cylindrical or trephine insertion portion.\nIt usually has an extremely sharp-edged saw blade or\na cutting blade with a thin saw blade. The blade is\nbeveled on one side. It is used for removal of the\nintervertebral disc, other hard tissues, or soft tissues.\nIt may have a speed control device. This is a gas-\ndriven device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Gastroscope,\nGeneral & Plastic\nSurgery",
   "INTENDED USE": "A gastroscope is a flexible tube that has a small light\nand a video camera attached to the end of it. The tube\ncan be used to take tissue samples by inserting\ninstruments such as small pincers.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "General\nelectrosurgical unit",
   "INTENDED USE": "A device accompanied by accessories that\ncuts/coagulates tissues with a high-frequency current\nor with the electricity/heat of the heating element. The\ndevice is used by a physician to confirm that an\nincision or coagulation is made as intended,\nmacroscopically or microscopically.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Laparoscope,\nGeneral & Plastic\nSurgery",
   "INTENDED USE": "\"These electrodes are intended for use in minimally\ninvasive surgical procedures where monopolar\nelectrosurgical cutting and coagulation are desired",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "LaparoscopyTray\"",
   "INTENDED USE": "\"Laparoscopy Tray is intended for single-use to\nenable a suitable trained health care professional to\nperform an laparoscopic procedure.\"",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Liposuction\ncatheter",
   "INTENDED USE": "A rigid tube inserted into the subcutaneous layer\ntransdermally for removal of fatty deposits. Aspiration\nis performed with an appropriate unit. This device is\nfor single-use.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Manual operating\ntable and\naccessories and\nmanual operating\nchair and\naccessories",
   "INTENDED USE": "A manual operating table and accessories and a\nmanual operating chair and accessories are\nnonpowered devices, usually with movable\ncomponents, intended to be used to support a patient\nduring diagnostic examinations or surgical\nprocedures.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Manually-operated\ndermatome",
   "INTENDED USE": "A hand-held surgical device used to sever a thin piece\nof skin for grafting, or to resect a small skin lesion. A\ndedicated blade is required for this purpose.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Powered suction\npump.",
   "INTENDED USE": "A powered suction pump is a portable, AC-powered\nor compressed air-powered device intended to be\nused to remove infectious materials from wounds or\nfluids from a patient's airway or respiratory support\nsystem. The device may be used during surgery in the\noperating room or at the patient's bedside. The device\nmay include a microbial filter",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Removable skin\nclip",
   "INTENDED USE": "A removable skin clip is a clip-like device intended to\nconnect skin tissues temporarily to aid healing. It is\nnot absorbable",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Removable skin\nstaple",
   "INTENDED USE": "A removable skin staple is a staple-like device\nintended to connect external tissues temporarily to aid\nhealing. It is not absorbable.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Reusable\ndermatome blade",
   "INTENDED USE": "A blade that comes in various sizes, attached to the\nskin graft knife, and is used to harvest the skin graft.\nThis device is reusable after sterilization. Usually, the\nblade point should be sharpened periodically.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Single-use\ndermatome blade",
   "INTENDED USE": "A blade, available in various sizes, attached to a\ndermatome for collection of skin grafts. The device is\nintended for single-use.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Surgical lamp",
   "INTENDED USE": "Identification. A surgical lamp (including a fixture) is a\ndevice intended to be used to provide visible\nillumination of the surgical field or the patient.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Surgical\nmicroscope and\naccessories.",
   "INTENDED USE": "A surgical microscope and accessories is an AC-\npowered device intended for use during surgery to\nprovide a magnified view of the surgical field.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Aerosol tent, paediatric",
   "INTENDED USE": "A flexible enclosure designed to cover the bed of a infant or small child to provide an aerosolized environment of breathing\ngases/vapours, e.g., a suspension of medicated liquid or solid particles, for medication therapy. Typically used for the treatment of\nbreathing disorders (e.g., asthma). It typically consists of a metal frame covered with transparent plastic, and wide bore tubing\nconnected to the aerosol source and is used for the treatment of paediatric patients permitting themmovement without restriction.\nThis is a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Airway Pressure /Oxygen Monitor",
   "INTENDED USE": "Amains electricity (AC-powered) device designed to continuously measure and display the breathing circuit pressure and oxygen (O2)\nconcentration levels of respiratory gases delivered to a patient through positive pressure ventilation systems such as continuous\npositive airway pressure (CPAP) systems or ventilator respiratory circuits. It typically includes pressure and O2 level displays, alarms\nto signal pressure and O2 levels that exceed specified limits, and has connectors to allow attachment to the respiratory equipment; it\nis used for neonatal, paediatrics and adults. It may contain one or more rechargeable battery for independent/mobile use or when\nmains power is not available.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Anaesthesia Facemask, single use\n(paediatric)",
   "INTENDED USE": "A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper\nairway. It is intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract for\nmicroorganisms and particulate materials. It may be stabilized with a headstrap. It is constructed of nonwoven materials such as\nconductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to\ncreate an airtight seal against the patient's face. It typically includes a 15 mm connector (paediatric), and is available in a range of\nsizes. This device is sometimes used in association with amanual resuscitator. It is a single use, disposable device that is provided non-\nsterile.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Anaesthesia Facemask, reusable\n(paediatric)",
   "INTENDED USE": "A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper\nairway. It is intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract for\nmicroorganisms and particulate materials. It may be stabilized with a headstrap. It is constructed of nonwoven materials such as\nconductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to\ncreate an airtight seal against the patient's face. It typically includes a 15mm connector (paediatric), and is available in a range of\nsizes. This device is sometimes used in association with a manual resuscitator. It is reusable.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Antimicrobial endotracheal tube,\npaediatric",
   "INTENDED USE": "A sterile hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to\nand from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated, and which is\ncoated with an antimicrobial agent [e.g., silver (Ag)] to help prevent infection. Itmay: 1) be packaged with a connector that will attach\nto a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4)\nhave a built-in pilot balloon. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use\ndevice.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Circulating-fluid whole-body\nheating/cooling system pad, single-\nuse",
   "INTENDED USE": "A non-sterile underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated with the intention to heat and\nalternatively cool a patient<6E>s whole body (i.e., elevate or lower core body temperature) as part of a circulating-fluid whole-body\nheating/cooling system typically used in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is\navailable in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-\nbody). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Closed-ended adhesive\ninfant/paediatric urine collection\nbag",
   "INTENDED USE": "A sterile, flexible plastic pouch with an adhesive flange (typically with a gender-specific shape) intended to be attached to the skin\naround the genitalia to collect urine from an infant/paediatric patient. It is not designed with an opening for urine drainage and is\ntypically used for biochemical, cytological and/or bacteriological sampling. This is a single-use device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Craniofacial bone screw,\nbioabsorbable",
   "INTENDED USE": "A small, sterile, threaded rodwith a slotted head used for craniofacial bone (including themaxilla and/or mandible) fracture fixation\nby being screwed into bone to hold plates to bone or to provide direct interfragmentary stabilization of bone; it is made of a material\nthat is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-\ndrilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive\nsurgery, and craniotomy flap fixation.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Craniofacial bone screw, non-\nbioabsorbable, sterile",
   "INTENDED USE": "A small, sterile, threaded rodwith a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the\nmaxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may\nalso be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically\ndegraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital\nfractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation\nprocedures.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cuff-suction endotracheal tube",
   "INTENDED USE": "A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged\nmechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a\nventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall;\nseparate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically\nhas a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is\na single-use device.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Electric pad whole-body heating\nsystem",
   "INTENDED USE": "An assembly of mains electricity (AC-powered) devices designed to heat a patient's whole body, to compensate for the loss of normal\nbody heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables. The system\nincludes the pad designed to heat under or over the patient, and a control unit to regulate and monitor the heat. The pads are\navailable in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-\n/partial-body). The system is typically used in the operating room (OR), the intensive care unit (ICU), or in neonatal and recovery\nunits.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Electric pad whole-body heating\nsystem pad",
   "INTENDED USE": "An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an electrical heating pad system\nused to heat a patient<6E>s whole body (i.e., elevate core body temperature) typically in surgical and intensive care settings. The\nunderlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The\nunderlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g.,\nadult/paediatric, full-/partial-body). This is a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Funnel chest remodelling bar",
   "INTENDED USE": "A non-sterile implantable device intended to be used to reduce the deformity of pectus excavatum (funnel chest) by applying\noutward force from aposition deep to the sternum to reposition the sternum; it is typically used in paediatric patients and surgically\nremoved when remodelling is evident (after 2-3 years). It is a thin curved bar, with or without serrations, made of metal [e.g.,\nstainless steel, titanium (Ti)] that can be anchored with wires or with stabilizer plates laterally on the rib cage; devices associated with\nimplantation may be included. This is a single-patient device intended to be sterilized prior to use.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Growth-correction orthopaedic\nfixation plate kit",
   "INTENDED USE": "A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates\n(epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or\nflexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone\nscrews to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that\nthe implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Hepatic ultrasound elastography\nsystem applicator",
   "INTENDED USE": "A non-sterile hand-held device designed to be used for the transcutaneous measurement of liver stiffness based on transient\nelastography. It includes an ultrasound transducer and an electrodynamic transducer intended to generate a controlled transient\nvibration that produces amechanical elastic shear wave propagated through the skin and liver; subsequent ultrasound measurements\ncan be used to calculate a measure of liver stiffness/ultrasonic attenuation of tissues. The device is designed to connect to a control\nunit and may be available in various forms for different applications [e.g., paediatric, bariatric (obese)]. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Infant apnoea monitor",
   "INTENDED USE": "Amains electricity (AC-powered) device that is used to register the respiratory rate of an infant and which gives an alarm signal (e.g.,\naudible/visual) when the pre-set limits are exceeded caused by an extended interruption or cessation (apnoea) of the infants\nbreathing pattern; a condition known as sudden infant death syndrome (SIDS). This will alert the infant's parent(s), child-minder or\nhospital staff when such life-threatening episodes occur. This device is usually connected to some form ofmovement sensing device,\ne.g., small pads placed directly under the infant or belts with sensors around the chest. It can be designed for use in the\nhospital/institution, or for home-use.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Infant bed crib top",
   "INTENDED USE": "A covering made of a metallic, plastic, or metallic/plastic combination structure designed for secure/permanent attachment to the\ntop of an infant bed (i.e., a cradle or crib) to protect the infant from accidental damage. Commonly called a crib top, it is typically a\nrigid structure with a flexible, transparent plastic (e.g., vinyl) covering around it forming a canopy that encloses the bed.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Infant bed restraint",
   "INTENDED USE": "A device designed to limit totally or partially the movement of infants and/or toddlers when lying in its bed or crib; this may be a belt\nor a strap, or to prevent them from falling out of a bed after climbing the bedrail (e.g., a cover or net). This is a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Infant care table",
   "INTENDED USE": "A specially made table used for nursing, e.g., washing or changing of nappies, of newborn babies. It can be equippedwith a washing\nbasin, typically of soft material (rubberized cloth), and a surface upon which to lie the infant for drying with a towel.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Infant heat shield",
   "INTENDED USE": "A protective guard intended to be used to reduce heat loss due to insensible water loss, i.e., evaporation, during the radiant warming\nof primarily premature infants. This is a single-use device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Infant whole-body immobilizer,\nreusable",
   "INTENDED USE": "A device intended to be used to temporarily render an infant's whole body immovable (strait-jacket effect) while the patient\nundergoes therapeutic or diagnostic interventions. It includes non-rigid fabric and/or plastic components but might also include a\nrigid structural component (e.g., board). This is a reusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Infant whole-body immobilizer,\nsingle-use",
   "INTENDED USE": "A non-sterile, non-rigid device, usually made of a fabric and/or plastic materials, intended to be used to temporarily render an infant's\nwhole body immovable (strait-jacket effect) while the patient undergoes therapeutic (e.g., phototherapy) or diagnostic interventions.\nThis is a single-use device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Infant/regional-body warmer",
   "INTENDED USE": "Amains electricity (AC-powered) device that contains an infrared (IR) heating element(s) designed to emit controlled, evenly\ndistributed heat to a newborn/infant patient requiring a supplemental regulated thermal environment, or to provide heat to the limbs\nof a more mature person, typically an adult, who has been severely burned or who is undergoing a procedure. This is a stationary\ndevice that is generally operated at a single site.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Infant-hammock bed mattress",
   "INTENDED USE": "A foam-filled casewith a central meshed/netted depression/hole designed to be placed in a cot/crib/bassinet/bed/incubator and to\ncradle a young infant during sleep/rest, and can used for phototherapy, transportation and burns patients. It is available in various\nshapes and sizes and is not intended to be placed on an existing mattress. The breathable netting is intended to help reduce the risk\nof infant injuries/disorders such as suffocation, flat head (plagiocephaly), sudden infant death syndrome (SIDS), pressure sores, and\nhyperthermia. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Infant-hammock bed mattress\noverlay",
   "INTENDED USE": "A portable pad with a central meshed/netted depression designed to be placed on a cot/crib/bed mattress and to cradle a young\ninfant during sleep/rest. The device is typically foam-filled andwedge-shaped with ventilation channels and securing ribbons. The\nbreathable netting is intended to help reduce the risk of infant injuries/disorders such as suffocation, flat head (plagiocephaly),\nsudden infant death syndrome (SIDS), and hyperthermia. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Internal defibrillator electrode,\npaediatric",
   "INTENDED USE": "An electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed\nheartmuscle of a pre-pubescent patient in order to intentionally stop/start the heartbeat during cardiopulmonary surgery. It usually\nconsists of a cable set with small-diameter, spoon-like electrodes (commonly known as internal defibrillator paddles or spoons) that\nare held by the operator directly to either side of the heart muscle so that the discharge passes directly through the heart. It is\ntypically available as a set of two electrodes with insulated handles with a combined cable/connector. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Lacrimal intubation set",
   "INTENDED USE": "A collection of sterile devices designed to prevent/treat obstruction of and drain tears from the lacrimal ducts. It typically consists of\na cannula for insertion into the lacrimal ducts, a tube (e.g., silicone) to perform various ocular irrigation or aspiration procedures (e.g.,\nlacrimal syringing), and a probe to remove ductal obstructions. It can be used for adult and paediatric patients, particularly to treat\ncanalicular pathologies (stenosis, obstruction, wounds, imperforation of the lacrimo-nasal canal in the infant), for prevention of viral\nand post-chemotherapy stenoses, or for dacryocystorhinostomy (DCR). This is a single-use device.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Liquid crystal vein locator",
   "INTENDED USE": "A non-sterile device designed tomeasure skin temperature at several different points using liquid crystal sensors (usually formed\nfrom esters of cholesterol which are sealed in a plastic band) placed on the skin around the forearm in order to assist a healthcare\nprofessional to locate peripheral veins in a patient before venipuncture. The device is used in paediatric, geriatric, and other patients\nwith hard-to-find veins. This is a single-use device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Neonatal kangaroo care garment",
   "INTENDED USE": "A non-sterile, upper body garment intended to allow a parent to safely carry/support their premature, dysmature, and/or sick infant\nin amanner which enables skin-to-skin contact between parent and infant (kangaroo care). It typically consists of a wrap/sweater\nwith a variety of straps, and pockets to accommodate ventilation, monitoring, feeding, and warming devices. This is a reusable\ngarment.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Neonatal physiologic monitoring\nsystem",
   "INTENDED USE": "A device assembly designed to continuously measure and display multiple vital physiological parameters of newborn and premature\ninfants, especially those under critical care. It is typically capable of monitoring parameters such as electrocardiogram (ECG),\nrespiration rate, heart rate, blood pressure, and body temperature; it may also assess haemoglobin oxygen saturation (SpO2) through\ntranscutaneous sensors that measure both transcutaneous oxygen (tcPO2) and transcutaneous carbon dioxide (tcPCO2) saturation.\nThe system typically includes sensors with appropriate size and design for infant use.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Neonatal pulmonary surfactant\ncatheter",
   "INTENDED USE": "A sterile, flexible, single-lumen tube intended to be introduced into the trachea of a neonate for the administration of exogenous\nsurfactant as part of pulmonary surfactant therapy. It may have a curved distal end to assist navigation into the trachea, and is usually\nused to treat neonates at a high-risk of infant respiratory distress syndrome [surfactant deficiency disorder (SDD)]. This is a single-use\ndevice.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Neonatal/paediatric heart rate\nmonitoring application software",
   "INTENDED USE": "An application software program intended to be installed in an off-the-shelf computer to acquire, record, measure and analyse an\nelectrocardiogram (ECG) signal or heart rate data from a physiological monitor. It typically detects variations in heart rate [e.g.,\ndecelerations, reduced baseline heart rate variability (HRV)] in real-time, and is typically used in the neonatal or paediatric intensive\ncare unit (ICU). This device is typically identified by a proprietary name and \"version\" or \"upgrade\" number.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Neonatal/paediatric heart rate\nmonitoring hardware",
   "INTENDED USE": "Amains electricity (AC-powered) device designed to be connected between a physiological monitor and an off-the-shelf computer,\ncontaining dedicated application software, and intended to function as a data acquisition node for real-time sampling of\nneonatal/paediatric patient electrocardiogram (ECG) waveforms for communication to the software for analysis of variations in heart\nrate. It typically consists of a microprocessor, random access memory (RAM), and analogue-to-digital sampling card, and is typically\nused in the neonatal or paediatric intensive care unit (ICU).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Nitric oxide delivery unit, system-\nbased",
   "INTENDED USE": "Amains electricity (AC-powered) device, whichmay include internal rechargeable batteries, intended for the delivery of precise\namounts of nitric oxide (NO), also known as nitrogenmonoxide, to the respiratory tract of neonate, paediatric, and adult patients to\ntreat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It\nconsists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a\nventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for\nmobility.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Non-rechargeable public semi-\nautomated external defibrillator\nelectrode, paediatric",
   "INTENDED USE": "An electrical conductor, with integral batteries and regulated by a dedicated external pulse generator (EPG), designed to create an\nelectrical shock(s) and defibrillate the heart (restore normal rhythm) to treat ventricular fibrillation or pulseless ventricular\ntachycardia in a pre-pubescent patient. It is a cartridge-type electrode, in pairs, with non-rechargeable batteries that provide the\nenergy to produce the electrical shock(s) after its adhesive pads are placed on the skin of the patient. This is a single-use device that is\nreplaced after a patient application or after elapse of its expiry date.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Orthopaedic medialization\ninstrument",
   "INTENDED USE": "A surgical instrument used to restore the anatomical andmechanical axes during orthopaedic correction osteotomies. It is typically\ndesigned as a robust block with a long, thin, adjusting rod running through its centre and an incremented measuring scale that\nenables the surgeon to gauge the adjustments made to the axes (the medialization). It is usually attached to a dedicated bone plate\nwhich is bridging the osteotomy site in order to achieve the correct offset of the two separated bone sections. It is typically made of\nhigh-grade stainless steel and can be used on adult and paediatric patients. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Oxygen administration hood,\npaediatric",
   "INTENDED USE": "A device consisting of a rigid/semi-rigid transparent plastic shell that forms an enclosure over an infant's whole body, or the head\nonly, in order to provide an enriched environment of oxygen (O2) to increase the patient's O2 uptake. It is connected to anO2 source\nand may be used concurrently with increased humidification and temperature control. It is designed to be used for patients adverse\nto oxygen delivery devices such as a nasal cannula or facemask. This device may include the tubing, a diffuser (to disperse the flow of\nincoming O2), O2 concentration and humidity sensors. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Oxygen administration tent,\nneonatal/paediatric",
   "INTENDED USE": "A flexible enclosure designed to cover the bed of a neonatal or small child to provide an enriched environment of oxygen (O2) to\nincrease the patient's O2 uptake. It is connected to anO2 source and may be used concurrently with increased humidification and\ntemperature control. It typically consists of a metal frame covered with transparent plastic, the tubing, and may have built-in\nhumidification. It is used for the treatment of breathing disorders in infant and paediatric patients permitting them movement\nwithout restriction. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Paediatric bed",
   "INTENDED USE": "A bed with appropriate size for children (typically up to 12 years of age) that incorporates safety canopy tops, fixed endrails, and\nmoveable and latchable siderails. It allows children complete freedom in bed without the danger of falling out, yet allows staff access\nto the patient. Paediatric beds are not appropriate for neonates/infants.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Paediatric blood donor set",
   "INTENDED USE": "A sterile assembly consisting ofmultiple collection containers (typically five connected flexible bags) of smaller volume than those\nused in adult sets. It is used for the storage of adult donor blood which is decanted from a normal adult size pack into this device in\norder to create smaller paediatric volume packs for infusion. The individual paediatric packs are then separated and sealed for later\ninfusion. This is a single-use device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Paediatric cardiopulmonary bypass\ncannula",
   "INTENDED USE": "A sterile tube intended to be used during open heart surgery on a paediatric patient (e.g., neonatal, infant) to access the arterial or\nvenous vasculature surrounding the heart (i.e., intended for both venous and arterial access), to serve as a channel intended to be\nconnected to an extracorporeal circuit for the transport of blood to or from acardiopulmonary bypass system (heart-lung machine)\ncircuit where the blood is pumped and oxygenated. It is typically a reinforced polymer tube whichmay include accessories/devices\ndedicated to introduction/function (e.g., introducer/connector). This is a single-use device.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Paediatric dental chair, electric",
   "INTENDED USE": "Amains electricity (AC-powered) device designed to support a paediatric patient in a seated position to facilitate dental examination,\ntreatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures\nwhile standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and\nhas rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination\nand/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or\nceiling-mounted units.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Mobile steamwasher/disinfector",
   "INTENDED USE": "Amobile, mains electricity (AC-powered) unit designed for the cleaning and high-level disinfection of a range ofmedical devices (e.g.,\noperating tables, operating lights, neonatal incubators, medical beds, chirurgical instruments) using steam. It includes an\nelectronically controlled boiler unit, for steam generation; hosing, for transfer of the steam; and a hand-held steam application\ndevice, typically including accessories (e.g., brush, nozzle, mop), in order to effectively direct steam onto themedical device being\ndisinfected.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Otoacoustic emission system,\nbattery-powered",
   "INTENDED USE": "An assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic\nemission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear\nduring diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and\neartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via amicrophone in the\nprobe; OAEs are absent/reduced in patients with hearing loss. The systemmay be combined with other audiological devices (e.g.,\ntympanometer, ABR device).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Otoacoustic emission system, line-\npowered",
   "INTENDED USE": "An assembly of mains electricity (AC-powered) devices designed to record and analyse the faint sounds hair cells in the inner ear emit\n[otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in\nthe ear during diagnostic evaluation and/or neonatal screening. It typically consists of a programmable unit, an OAE probe, and\neartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via amicrophone in the\nprobe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g.,\ntympanometer, ABR device).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Overhead infant phototherapy unit",
   "INTENDED USE": "A mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat\nneonatal jaundice (hyperbilirubinemia). It consists of an overhead lamp consisting of several, daylight, cool white, blue, or special blue\nfluorescent light tubes and a Plexiglas shield placed between the phototherapy lights and the newborn to filter out ultraviolet (UV)\nradiation. Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization,\nallowing the body to dispose of it naturally. It will typically have a built-in timer, but somemay have a separate timer unit connected.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Phototherapy eye protector,\nreusable",
   "INTENDED USE": "A device worn to cover and protect the eyes of a patient or user from potentially harmful rays [e.g., ultraviolet (UV)] to which parts,\nor all, of their body is intentionally exposed during light therapy treatment. It will typically be designed as goggles, special spectacles,\nor amechanical mask-like shield with properties to block or inhibit the transmission of rays to the eyes. It will come in a variety of\nsizes, e.g., premature infant, neonatal, child, and adult. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Phototherapy eye protector, single-\nuse",
   "INTENDED USE": "A device worn to cover and protect the eyes of a patient from potentially harmful rays [e.g., ultraviolet (UV)] to which their body is\nintentionally exposed during light therapy treatment. It will typically be designed as amechanical mask-like shieldwith properties to\nblock or inhibit the transmission of rays to the eyes. It will typically be made of soft materials in a variety of sizes, e.g., premature\ninfant, neonatal and affix to the head using bands, hooks, Velcro fasteners, and/or adhesive fasteners. This is a single-use device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Respiratory gas heating wire, infant",
   "INTENDED USE": "A non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory\nhumidifier (fromwhich it draws its power) tomaintain the temperature of inspiratory gases during ventilation of an infant/neonate. It\ntypically consists of a compact heating unit and a length of heated wire which is integrated within the lumen of a neonatal/paediatric\nbreathing circuit tube. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Newborn-infant bed",
   "INTENDED USE": "A bed designed for newborn babies. It is usually an open rectangular receptacle, and mounted on awheeled framework (trolley). It is\npadded or lined with appropriate bedding and usedmostly as the general-purpose or standard baby bed in birthing departments. A\nsource of additional heating may be provided to the newborn.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Resuscitator face mask, reusable",
   "INTENDED USE": "A flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air,\nfrom a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will\ncreate a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes\n(baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is\nintended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Resuscitator facemask, single-use",
   "INTENDED USE": "A non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen\n(O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g.,\nsilicone) that will create a gastight seal against the face. It will typically include a 15mm and/or 22 mm connector and is available in a\nrange of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator.\nThis device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use\ndevice.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Warming infant bed, adjustable",
   "INTENDED USE": "A mains electricity (AC-powered) bed specifically designed for a newborn, sick, or premature baby that requires additional heating\nprovided by a heating pad system. It is typically ergonomically designed for the attending/nursing staff or parents and themotorized\nmechanism is used to electrically adjust the height and possibly tilt the bed to provide better access to the baby. Itmay be equipped\nwith features such as shelves, drawers, a canopy, and is typically used in the maternity department.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Warming infant bed, non-adjustable",
   "INTENDED USE": "A non-adjustable bed (has a fixed height andmattress platform) specifically designed for a newborn, sick, or premature baby that\nrequires additional heating provided by a heating pad system. It is typically ergonomically designed to provide good access to the\nbaby by the attending/nursing staff or parents. Itmay be equipped with features such as shelves, drawers, a canopy, and is typically\nused in the maternity department.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Bedrail pad",
   "INTENDED USE": "A device which is formed as a flat or contoured fitted cushionmade of soft, non-irritatingmaterials designed to protect the patient\nfrom coming into contact with the bedrails and inadvertently hurting or injuring themselves. It will be mainly used for patients that\nhave little self-control, infants and very young children. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Blanket/pad infant phototherapy\nunit tester",
   "INTENDED USE": "A portable device intended to be used in conjunction with a light meter to test a blanket/pad infant phototherapy unit. The\nphototherapy unit is typically positioned over specific areas of the test device at set distances to provide a measurement of light, such\nas average light output. It typically consists of a plastic stencil-like shape designed so the radiometer may fit at a number of positions.\nIt is intended to be used by a healthcare professional in a clinical setting.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Blood transfusion set, exchange",
   "INTENDED USE": "A sterile, intravascular administration set used to remove a diseased infant's blood and replace it with fresh donor blood or plasma.\nThe device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock,\nconnectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect\nthe tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Nappy changing table, portable",
   "INTENDED USE": "A raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the\npatient easily rolling off) mounted on a foldable frame with legs designed to support an infant, child or an adult during nappy (diaper)\nchanging. The device is used primarily for a patient with a disability who is incontinent and requires regular changing of their nappies.\nIt is designed to be portable for transport to different locations.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Nasal aspirator, electric",
   "INTENDED USE": "A portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from\nthe nasal passages of an infant or child to facilitate easier breathing. It consists of a handgrip that contains the batteries, a small\nelectric pump that creates the suction, and typically has a silicone nozzle attached to a detachable, washable, collection cup at the\ndistal end. It is designed for domestic use and is typically applied superficially the nasal opening (i.e., not inserted into the nasal\ncavity). This is a reusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Open infant incubator",
   "INTENDED USE": "Amains electricity (AC-powered) unit that functions similar to a standard infant incubator but is open, having low side walls and no\ntop enclosure, giving instant access to the infant. Such infants are not premature but suffer from disorders where intensive care is\nrequired. This device is equipped with overhead heating lamp(s), oxygen therapy flowmeter, gas mixer, suction system, facilities for\ninfusion pumps, and other equipment. The main difference between this device and a closed infant incubator is the inability of this\ndevice to regulate the oxygen environment surrounding the occupant.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Oral medicine dropper",
   "INTENDED USE": "A device designed for aspirating a small volume of liquid medicine so that it can be dispensed in single drops into a patient's mouth,\ntypically an infant or small child. It is typically designed as a hollow tube, open at both ends, with an aspiration bulb attached to the\nproximal end and a narrow opening at the distal end. It is usually made of glass or plastic with a rubber teat. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Oxygen breath analyser",
   "INTENDED USE": "Amains electricity (AC-powered) laboratory instrument designed for intermittent/periodic measurements of oxygen (O2) content in a\nbreath and/or respiratory gas specimen. It usually requires manual aspiration of a quantity of gas into a sampling chamber and may\noperate according to one of several basic principles (e.g., paramagnetism, polarography). The device is used in pulmonary function\ntests and formeasurements in critically ill patients, such as infants in incubators and patients breathing air with supplemental oxygen.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Oxygen terminal unit",
   "INTENDED USE": "A device that is a component of a medical gas pipeline system or a medical gas/vacuum pipeline system that has a gas-specific outlet\nconnection for oxygen (O2). It is designed to be mounted to wall-mounted medical supply units, utility supply systems (ceiling\npendants), or directly to a wall, and functions as the outlet assembly of a gas pipeline system to which the operator can connect and\ndisconnect a device, typically anaesthesia systems, ventilators, respiratory devices, infant incubators, and other devices that require\nO2 to function as intended. On disconnection of the medical device from the outlet, it will self seal the gas pipeline system preventing\ngas leakage to the environment.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Pulmonary function analysis system,\npaediatric",
   "INTENDED USE": "A computerized instrument designed to assess lung volume, flow, and mechanical parameters (including airway compliance and\nresistance) in young children and infants. It is different from an adult version in absolute dimensions and in the special procedures\nrequired for adaption to the pediatric patient (e.g., use of a small constant-volume chamber in which the infant reclines for\nplethysmography, use of a pressure jacket to obtain forced exhalation); also, parameters that require subject cooperation (e.g., vital\ncapacity, forced expiratory volume) can't be determined. The device is used for pulmonary function testing in diagnostic studies and\nfor evaluation of diseases and chest deformities.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "FerriScan R2-MRI Analysis System",
   "INTENDED USE": "The FerriScan R2-MRI Analysis System is intended to measure liver iron\nconcentration to aid in the identification and monitoring of non-\ntransfusiondependent thalassemia patients receiving therapy with deferasirox.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Activated-oxygen generator",
   "INTENDED USE": "Activated Oxygen (Ozone) Activated oxygen, also known as Ozone (O3), is a safe\ndisinfecting agent that SoClean uses to get rid of CPAP bacteria, mold or viruses\ninside your CPAP equipment",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Alternating electric field\nantimitotic cancer treatment\nsystem generator",
   "INTENDED USE": "Alternating electric fields therapy is a novel anticancer treatment that disrupts\ntumor cell mitosis.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Alternating electric field\nantimitotic cancer treatment\nsystem transducer array",
   "INTENDED USE": "Alternating electric fields therapy is a novel anticancer treatment that disrupts\ntumor cell mitosis.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Bladder instillation buffer solution",
   "INTENDED USE": "A sterile buffer solution intended to be used exclusively for bladder instillation to\nhelp create an optimal environment necessary for the effective treatment of\nsuperficial bladder cancer with a chemotherapy agent.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Brachytherapy needle",
   "INTENDED USE": "A sterile, sharp bevel-edged, hollow tubular metal instrument that is used to\ninject radionuclide into a body cavity or tissue as a source of nuclear radiation\nfor cancer therapy (brachytherapy).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Breast 3-D infrared\nimaging/vascular analysis system",
   "INTENDED USE": "An assembly of mains electricity (AC-powered) devices intended for three-\ndimensional (3-D) breast imaging and breast vascular analysis, typically used with\nmammography screening to perform a breast cancer risk examination.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Balloon kyphoplasty kit",
   "INTENDED USE": "A collection of sterile surgical instruments and devices used for the reduction of\na vertebral compression fractures (VCFs) caused by trauma, cancer, or\nosteoporosis during aminimally invasive procedure commonly known as balloon\nkyphoplasty.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Brachytherapy radionuclide\nphantom, anthropomorphic",
   "INTENDED USE": "A device that consists of preserved human or animal tissue, or a two or three-\ndimensional (3-D) tissue-equivalent model designed to simulate the functional,\nphysical, or a combination of these characteristics of normal or diseased human\norgans.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Accelerator system chair",
   "INTENDED USE": "A seat, typically with legs, that is a component of a therapeutic accelerator\nsystem, and used to support and position a seated patient during radiation\ntherapy treatments involving the use of either a medical linear accelerator or\nnon-linear accelerator.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Accelerator system operator\nconsole",
   "INTENDED USE": "A device that is a component of a linear or a non-linear accelerator system that\nfunctions as the primary control panel typically for a betatron or cyclotron\nsystem. Depending on the configuration, it can include hardware and software\nthat allows for image and/or data display, related processing, analysis functions,\ndata archiving and retrieval.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Accelerator system quality\nassurance device",
   "INTENDED USE": "An instrument specifically designed to be used to check the calibration and\nperformance of linear and non-linear medical accelerator systems used for\nradiation therapy applications, for quality assurance (QA) purposes",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Acupressure wristband",
   "INTENDED USE": "A device designed to be worn on the wrist(s) for the application of pressure to\nthe Nei-kuan (P6) acupressure point, the area identified to help relieve the\nsensation of nausea.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Anorectal brachytherapy system\napplicator, manual",
   "INTENDED USE": "Amanual brachytherapy applicator specifically designed to be used in radiation\ntherapy treatments of the rectum and/or anus.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Anorectal brachytherapy system\napplicator, remote-afterloading",
   "INTENDED USE": "A remote afterloading brachytherapy applicator specifically designed for use in\nradiation therapy treatments of the rectum and/or anus.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Brachytherapy system chair",
   "INTENDED USE": "Amains electricity (AC-powered) device (a chair or stool) that is a component of\na brachytherapy system and which is specifically designed to support and\nposition a patient during brachytherapy radiation treatments given by either a\nmanual applicator or a remote afterloading brachytherapy system applicator. It\nwill typically be height-adjustable and may have a reclining back.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Brachytherapy system remote\nafterloading source safe",
   "INTENDED USE": "A component of a remote afterloading brachytherapy system consisting of a\nshielded vault, and associated source retraction and extrusion mechanisms,\nalarms, and related mechanical, electronic and software controls, used to shield\nthe brachytherapy sources in order to protect system operators, brachytherapy\npatients and others from the continuous emissions of the radioactive\nbrachytherapy source(s) when they are not in use.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Brachytherapy system remote\nafterloading source transfer tube",
   "INTENDED USE": "A tube or hose-like catheter with connectors at both ends used to interface the\nbrachytherapy applicator to the remote afterloading system.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Brachytherapy system remote-\nafterloading operator console",
   "INTENDED USE": "A mains electricity (AC-powered) component of a remote-afterloading\nbrachytherapy system intended to function as the primary control panel for the\nremote afterloader. It typically includes hardware and software that allows for\ninformation display and/or transfer, data processing, analysis, and information\narchiving functions; it may also be intended to interface with other devices (e.g.,\nradiation therapy treatment planning computer) as part of a picture archiving\nand communication system (PACS).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Brain brachytherapy system\napplicator, manual",
   "INTENDED USE": "A device specifically designed to be used in radiation therapy treatments of the\nbrain. It has individual or modular device configurations designed to facilitate\nmanual placement, e.g., puncture, endoscopically guided placement or\ndiagnostic imaging guided placement, and removal of single or multiple\nradioactive sources at a treatment site within the brain.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Cervical cone knife",
   "INTENDED USE": "A surgical, manually-operated, instrument that is inserted into the vagina and\ndesigned for excising a sample of abnormal tissue, e.g., indicated by the presence\nof precancerous changes, from the cervix.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Cervical cytology scraper,\nreusable",
   "INTENDED USE": "blunt surgical instrument used to scrape and retrieve cytological material from\nthe surface of the cervix (neck of the uterus) or vaginal area for pathological\nexamination and diagnosis, often for the detection of cervical cancer. This is a\nreusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Cervical cytology scraper, single-\nuse",
   "INTENDED USE": "A hand-held, manual, blunt surgical instrument designed to scrape and retrieve\ncytological material from the surface of the cervix (neck of the uterus) or vaginal\narea for pathological examination and diagnosis, often for the detection of\ncervical cancer. This is a single-use device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Cervical/intrauterine\nbrachytherapy system applicator,\nmanual",
   "INTENDED USE": "Amanual brachytherapy applicator specifically designed to be used in cervical\nand/or intrauterine radiation therapy treatments. It is an individual or modular\ndevice designed to facilitate manual placement, e.g., puncture, endoscopically\nguided placement or diagnostic imaging system guided placement, of single or\nmultiple radioactive sources at a treatment site.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Cervical/intrauterine\nbrachytherapy system applicator,\nremote-afterloading",
   "INTENDED USE": "A remote afterloading brachytherapy applicator specifically designed for use in\ncervical or intrauterine radiation therapy treatments. It is designed for temporary\nimplantation within the body and serve as a guide for computer-controlled\nplacement and removal of single or multiple radioactive sources in the cervical or\nintrauterine anatomy. This device includes a wide variety of applicators, e.g.,\nhollow needles, tubes, or catheters, and their associated components.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Class-I biological safety cabinet",
   "INTENDED USE": "A furniture-like device designed as a partial or total enclosure to provide a class I\nbiosafety level (BSL) to the operator and the environment during the\nmanipulation of microorganisms and other biological hazardous materials.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Externally-propelled flexible video\ncolonoscope",
   "INTENDED USE": "A non-sterile endoscope with a highly flexible sleeve and distal tip intended for\nthe visual examination of the entire adult colon [lower gastrointestinal (GI)\ntract].It is used for the screening of colorectal cancer and the detection of other\ndiseases of the lower GI tract. This is a single-use device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Extravascular-circulation\nhyperthermia system",
   "INTENDED USE": "An assembly of devices designed to produce and control heated fluids circulated\nwithin a vessel applied to the body (e.g., vest, mattress, jacket, band, pad, body\nwrap, catheter, probe) for systemic or localized heating to treat malignant\ntumours, benign growths, or other disease-related conditions.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Extravascular-circulation\nhyperthermia system applicator,\nextracorporeal",
   "INTENDED USE": "A vessel applied to the outside of the body (e.g., in the form of a jacket, vest,\nbody wrap, cushion, blanket, or mattress) that incorporates tubing through\nwhich heated fluids are circulated for systemic or localized heating to treat\nmalignant tumours, benign growths, or other disease-related conditions. he\napplicator typically includes a thermometry component that monitors the\ntemperature of the applicator during operation. The applicator includes tubing,\ncables, and connectors that interface with the hyperthermia system's control\nunit during treatments. It is typically used in an oncology department. This is a\nreusable device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible fibreoptic duodenoscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the duodenum (the first part of the small\nintestine). It is inserted into the body through the mouth during duodenoscopy.\nAnatomical images are transmitted to the user by the device through a fibreoptic\nbundle. This device is commonly used to examine structures and mucous\nmembranes of the duodenum, for conditions like ulcers, polyps and cancers. This\nis a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible fibreoptic gastroscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the oesophagus and the stomach. It is inserted\ninto the body through the mouth during gastroscopy. Anatomical images are\ntransmitted to the user by the device through a fibreoptic bundle. This device is\ncommonly used in the evaluation or treatment of unusual abdominal pain,\nbleeding, cancer, chronic heartburn, polyps, gastritis, ulcers, or hiatal hernia.\nPhysicians may also use the device to obtain biopsies or perform other\nprocedures. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible fibreoptic\nmediastinoscope",
   "INTENDED USE": "An endoscope with a flexible inserted portion intended for the visual\nexamination and treatment of the mediastinum (the intrapleural space located\nbehind the sternum). It is inserted into the body through an artificial orifice\ncreated by an incision made during mediastinoscopy. Anatomical images are\ntransmitted to the user by the device through a fibreoptic bundle. This device is\ncommonly used to examine structures such as lymph nodes during a staging\nevaluation of lung cancer, or to establish the diagnosis of a tumour that is\nlocalized to the mediastinum. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "General-purpose infusion pump,\nmechanical, reusable",
   "INTENDED USE": "A non-electric, mechanically-powered (e.g., a spring mechanism) device designed\nfor the continuous or intermittent infusion of medication, typically for antibiotic\ntherapy, chemotherapy, or pain management by intravenous (IV), subcutaneous,\nintramuscular, or epidural routes. It is primarily designed to be worn by the\npatient during ambulation in the home. It may be used for patient-controlled\nanalgesia (PCA), and may include mechanical indicators for flow and fluid level\nstatus. This is a reusable device.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Flexible video bronchoscope,\nreusable",
   "INTENDED USE": "An endoscope with a flexible inserted portion for endoscopic procedures of the\nairways and tracheobronchial tree (i.e., bronchoscopy). It is inserted through the\nmouth or nose during bronchoscopy. Anatomical images are transmitted to the\nuser by a video system with a charge-coupled device (CCD) chip at the distal end\nand the images showing on a monitor. It is commonly used to diagnose lung\ninfections, pneumonia, or lung cancer, and allows physicians to view the insides\nof the lungs and take biopsies and samples of secretions. This is a reusable\ndevice.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Medical charged-\nparticle radiation\ntherapy system",
   "INTENDED USE": "A medical charged-particle radiation therapy system is a\ndevice that produces by acceleration high energy charged\nparticles (e.g., electrons and protons) intended for use in\nradiation therapy.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Absorbable perirectal\nspacer",
   "INTENDED USE": "An absorbable perirectal spacer is composed of\nbiodegradable material that temporarily positions the\nanterior rectal wall away from the prostate during\nradiotherapy for prostate cancer with the intent to reduce\nthe radiation dose delivered to the anterior rectum.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Absorbable tissue\nspacer for radiotherapy",
   "INTENDED USE": "An absorbable material used to reduce radiation exposure\nof normal tissue during radiotherapy by implanting surgically\nor percutaneously between tissue, internal organs, etc. , to\nmake a space between the malignant tumor and normal\ntissue.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for bile duct\nmanual brachytherapy",
   "INTENDED USE": "A manual brachytherapy applicator specifically designed for\nbile duct radiation therapy. An applicator designed to have a\nconfiguration that facilitates manual placement (puncture or\nplacement and removal using an endoscope or a diagnostic\nimaging system) of single or multiple therapeutic radiation\nsources in treatment sites in the bile duct.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for\nbrachytherapy non-\ncentral circulatory\ngeneral-purpose\nmanual",
   "INTENDED USE": "A general-purpose brachytherapy applicator used to\nfacilitate radiotherapy. A single or module applicator\ndesigned to facilitate manual placement (puncture, local\nplacement, placement under endoscopy, and placement\nand removal using an image diagnostic system) of single or\nmultiple therapeutic radiation sources in treatment sites in\nthe non-central circulatory system.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for\nbrachytherapy non-\ncentral circulatory\ngeneral-purpose\nremote afterloading",
   "INTENDED USE": "A general-purpose remote controlled brachytherapy\napplicator used to facilitate radiotherapy. It is designed to\nbe temporarily implanted in the body. It serves as a guide\nfor computer-controlled temporary placement and removal\nof a single or multiple therapeutic radiation sources at\ntreatment sites in the non-central circulatory system.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for bronchial\nmanual brachytherapy\napplicator",
   "INTENDED USE": "A manual brachytherapy applicator specifically designed for\ntemporarily use in bronchial radiation therapy. A single or\nmodule applicator designed to facilitate manual placement\n(placement using an endoscope or positioning, placement\nand removal using a diagnostic imaging system) of single or\nmultiple therapeutic radiation sources in treatment sites. It\nmay be designed to be standard in configuration or to\nhandle specific radiation sources.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for\nesophagus remote\nafterloading\nbrachytherapy",
   "INTENDED USE": "A remote controlled brachytherapy applicator specifically\ndesigned for esophagus radiation therapy. It is designed to\nbe temporarily implanted in the esophagus. It serves as a\nguide for computer-controlled temporary placement and\nremoval of a single or multiple therapeutic radiation\nsources. This device group includes various applicators\nsuch as hollow needles, tubes, and catheters, as well as\nassociated devices and connectors.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for eye\nmanual brachytherapy",
   "INTENDED USE": "A template with a groove on the one side. The groove\nshows the position of the brachytherapy source that is\nmanually, temporarily delivered to the eye surface. The\nother side is shielded.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for manual\ncervical/endometrial\nbrachytherapy",
   "INTENDED USE": "A manual brachytherapy applicator specifically designed for\nuterine cervix or intrauterine radiation therapy. A single or\nmodule applicator designed to facilitate manual placement\n(puncture, placement with an endoscope or a diagnostic\nimaging system) of single or multiple therapeutic radiation\nsources in treatment sites.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for neck\nremote afterloading\nbrachytherapy",
   "INTENDED USE": "A remote controlled brachytherapy applicator specifically\ndesigned for neck radiation therapy. It is designed to be\ntemporarily implanted in the neck tissues. It serves as a\nguide for computer-controlled temporary placement and\nremoval of a single or multiple therapeutic radiation\nsources.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for pancreas\nmanual brachytherapy",
   "INTENDED USE": "A manual brachytherapy applicator specifically designed for\npancreatic radiation therapy. A single or module applicator\ndesigned to facilitate manual placement (puncture,\nendoscopic placement, or placement and removal using a\ndiagnostic imaging system) of single or multiple therapeutic\nradiation sources in treatment sites in the pancreas. It may\nbe designed to be standard in configuration or to handle\nspecific radiation sources.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for pancreas\nremote afterloading\nbrachytherapy",
   "INTENDED USE": "A remote controlled brachytherapy applicator specifically\ndesigned for pancreatic radiation therapy. It is designed to\nbe temporarily implanted in the pancreas. It serves as a\nguide for computer-controlled temporary placement and\nremoval of a single or multiple therapeutic radiation sources\nat treatment sites.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for tongue\nremote afterloading\nbrachytherapy",
   "INTENDED USE": "A remote controlled brachytherapy applicator specifically\ndesigned for tongue or oral cavity radiation therapy. It is\ndesigned to be temporarily implanted in the tongue or the\nsurrounding tissues. It serves as a guide for computer-\ncontrolled temporary placement and removal of a single or\nmultiple therapeutic radiation sources.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for vaginal\nmanual brachytherapy",
   "INTENDED USE": "A manual brachytherapy applicator specifically designed for\nvaginal or transvaginal radiation therapy. A single or module\napplicator designed to facilitate manual placement\n(puncture, local placement, endoscopic placement or\nplacement and removal using a diagnostic imaging system)\nof single or multiple therapeutic radiation sources in\ntreatment sites.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Applicator for vaginal\nremote afterloading\nbrachytherapy",
   "INTENDED USE": "A remote controlled brachytherapy applicator specifically\ndesigned for vaginal or transvaginal radiation therapy. It is\ndesigned to be temporarily implanted in the body. It serves\nas a guide for computer-controlled temporary placement\nand removal of a single or multiple therapeutic radiation\nsources in the vagina.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Bile duct\nbrachytherapy system\napplicator, remote-\nafterloading",
   "INTENDED USE": "A remote afterloading brachytherapy applicator specifically\ndesigned for use in radiation therapy treatments of the bile\nduct. It is designed for temporary insertion into the bile duct\nand serve as a guide for computer-controlled placement\nand removal of single or multiple radioactive sources.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Brachytherapy system\nchair",
   "INTENDED USE": "A mains electricity (AC-powered) device (a chair or stool)\nthat is a component of a brachytherapy system and which is\nspecifically designed to support and position a patient\nduring brachytherapy radiation treatments given by either a\nmanual applicator or a remote afterloading brachytherapy\nsystem applicator.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Brachytherapy system\nremote afterloading\nsource safe",
   "INTENDED USE": "A component of a remote afterloading brachytherapy\nsystem consisting of a shielded vault, and associated\nsource retraction and extrusion mechanisms, alarms, and\nrelated mechanical, electronic and software controls, used\nto shield the brachytherapy sources in order to protect\nsystem operators, brachytherapy patients and others from\nthe continuous emissions of the radioactive brachytherapy\nsource(s) when they are not in use.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Brachytherapy system\nremote afterloading\nsource transfer tube",
   "INTENDED USE": "The transfer tube, when attached to the applicator and the\nafterloading system, provides a continuous closed passage\nthat allows for moving either a radioactive source(s) and/or\npositioning markers from the shielded source storage\ncompartment of the remote afterloading brachytherapy\nsystem into appropriate positions within a brachytherapy\napplicator that has been positioned at a location either on\nthe surface of, or within, the patient.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Brain brachytherapy\nsystem applicator,\nremote-afterloading",
   "INTENDED USE": "A remote afterloading brachytherapy applicator specifically\ndesigned for use in radiation therapy treatments of the\nbrain. It is designed for temporary implantation within the\nbody and serve as a guide for computer-controlled\nplacement and removal of single or multiple radioactive\nsources in the brain.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Central circulatory\nmanual brachytherapy\ntherapeutic\nradionuclide system",
   "INTENDED USE": "A device that places a radiation source manually or\nautomatically at the treatment site in the central circulatory\nsystem for providing a required radiation dose during\nradiotherapy. This device does not equip a remotely\ncontrolled radiation source transporter.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Central circulatory\npermanent implant\nmanual brachytherapy\ntherapeutic\nradionuclide source",
   "INTENDED USE": "A device for the central circulatory system to be placed\npermanently in the body for radiotherapy which is necessary\nfor treatment and symptomatic therapy, and uses natural\nradioisotopes or radioisotopes produced by an accelerator\nor a nuclear reactor. The radiation source, which is\npermanently placed manually, is designed to achieve\ncompatibility with tissues. The radiation source can be\nselected from the following forms <20> e.g., microsphere,\nglobe, stent, seed, and wire-in order to generate low-energy\nphotons, beta particles, or alpha particles.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Central circulatory\nremote afterloading\nbrachytherapy\ntherapeutic\nradionuclide source",
   "INTENDED USE": "A device for the central circulatory system used as radiation\nsource to deliver a high or low dose rate with an after-\nloading brachytherapy device designed for radiotherapy\nwhich is necessary for treatment and symptomatic therapy,\nand uses natural radioisotopes or radioisotopes produced\nby an accelerator or a nuclear reactor.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Intra-vaginal organ\npositioning device for\ndiagnostic imaging and\nradiotherapy",
   "INTENDED USE": "A device that is specifically designed to be inserted in the\nvagina to properly position and fix the surrounding organs\nsuch as uterine cervix, rectum, and urinary bladder for\nimage diagnosis or radiotherapy. This device is used to\nfacilitate reproducible positioning for continuous image\nexamination or continuous radiotherapy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Laser irradiation\ntherapy kit",
   "INTENDED USE": "A kit includes a puncture needle, a guide wire, and a\nguiding sheath for guiding probes (used for laser irradiation\ntherapy, for example). Not all of the components are\nincluded; in some products, two or more of components are\nintegrated into one.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Light beam patient\nposition indicator",
   "INTENDED USE": "A light beam patient position indicator is a device that\nprojects a beam of light (incoherent light or laser) to\ndetermine the alignment of the patient with a radiation\nbeam.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Living tissue\nradiotherapy system",
   "INTENDED USE": "A low energy X-ray therapy system designed to treat\nadjacent tumor lesions with high dose X-rays by placing soft\nX-ray beams from 5 to 50 kV inside the tumor tissue. T It is\nused in both intraoperative radiation and stereotactic\nlocalized radiation therapy.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Manual radionuclide\napplicator system",
   "INTENDED USE": "A manual radionuclide applicator system is a manually\noperated device intended to apply a radionuclide source\ninto the body or to the surface of the body for radiation\ntherapy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Non-central circulatory\nremote afterloading\nbrachytherapy\ntherapeutic\nradionuclide source",
   "INTENDED USE": "A device for the non-central circulatory system used as\nradiation source to deliver a high or low dose rate with an\nafter-loading brachytherapy device designed for\nradiotherapy which is necessary for treatment and\nsymptomatic therapy, and uses natural radioisotopes or\nradioisotopes produced by an accelerator or a nuclear\nreactor.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Non-central circulatory\nremote afterloading\nbrachytherapy\ntherapeutic\nradionuclide system",
   "INTENDED USE": "A device that places a radiation source temporarily at the\ntreatment site in the non-central circulatory system for\nproviding a required radiation dose during radiotherapy.\nThis device equips a remotely controlled radiation source\ntransporter.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Non-central circulatory\ntemporary placement\nmanual brachytherapy\ntherapeutic\nradionuclide source",
   "INTENDED USE": "A non-central cardiovascular device containing an isotope\nnaturally occurring or produced by an accelerator or a\nnuclear reactor, intended to be temporarily implanted in the\nbody and to be removed after a prescribed duration of\ntreatment. Used in brachytherapy, the device is placed and\nremoved manually or under endoscopic observation.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Non-powered\naccelerator system\ntable",
   "INTENDED USE": "A mechanically-operated bed for radiotherapy designed to\nadjust the patient's posture and immobilize the patient for\nradiotherapy that uses a medical linear accelerator or non-\nlinear accelerator.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Patient positioning\ndevice for breast\ndiagnostic imaging and\nradiotherapy",
   "INTENDED USE": "A device that is specifically designed to properly position\nand fix a female patient's breasts and chest for image\ndiagnosis, image-guided surgery, interventional therapy, or\nradiotherapy.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Patient positioning\ndevice for extremity\ndiagnostic imaging and\nradiotherapy",
   "INTENDED USE": "A device that is specifically designed to properly position\nand fix a patient's arms and legs for image diagnosis, image\nguided surgery, interventional therapy, or radiotherapy.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Patient positioning\ndevice for pelvis\ndiagnostic imaging and\nradiotherapy",
   "INTENDED USE": "The device that consists of frames, plates, or other parts,\nand is specifically designed to properly position and fix the\npatient's abdomen and pelvic region for image diagnosis,\nimage-guided surgery, interventional therapy, or\nradiotherapy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Patient positioning\ndevice for whole body\ndiagnostic imaging and\nradiotherapy",
   "INTENDED USE": "A device that consists of fixed or adjustable parts (e.g.,\nframes and plates), and is specifically designed to properly\nposition and fix the patient's whole body for image\ndiagnosis, image-guided surgery, interventional therapy, or\nradiotherapy.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Post Breast Biopsy\nHemostatic Breast\nCompression Device",
   "INTENDED USE": "A mammographic x-ray system is a device intended to be\nused to produce radiographs of the breast.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Powered neutron\ntherapy table",
   "INTENDED USE": "A programmable bed for radiotherapy designed to adjust\nthe patient's posture and immobilize the patient for\ntreatment that uses neutron rays that are generated from\nthe nuclear reactor, etc.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Radiation therapy\nsimulation system",
   "INTENDED USE": "A radiation therapy simulation system is a fluoroscopic or\nradiographic x-ray system intended for use in localizing the\nvolume to be exposed during radiation therapy and\nconfirming the position and size of the therapeutic\nirradiation field produced.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Radio-frequency\nablation system",
   "INTENDED USE": "A system that heats and cauterizes malignant or benign\ntumors, etc. with radio wave energy.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Radio-frequency lesion\ngenerator system with\nprobe",
   "INTENDED USE": "A device that administers a high-frequency electric current\n(radio frequency) to the internal nerves in order to increase\ntemperature in a controlled way to create a therapeutic\nlesion.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Radiographic\nProtective Glove",
   "INTENDED USE": "A personnel protective glove is a device intended for\nmedical purposes to protect the patient, the operator, or\nother persons from unnecessary exposure to radiation\nduring radiologic procedures by providing an attenuating\nbarrier to radiation",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Radionuclide\nbrachytherapy source",
   "INTENDED USE": "A radionuclide brachytherapy source is a device that\nconsists of a radionuclide which may be enclosed in a\nsealed container made of gold, titanium, stainless steel, or\nplatinum and intended for medical purposes to be placed\nonto a body surface or into a body cavity or tissue as a\nsource of nuclear radiation for therapy",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Radionuclide dynamic\nfunction testing\nequipment",
   "INTENDED USE": "A device used to measure and record temporal variations of\nradioisotope concentrations in the body. Specialized\ndevices, such as devices for thyroid uptake measurement,\nrenograms, and radioisotope blood volume measurement,\nare included.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Remote controlled\nradionuclide applicator\nsystem",
   "INTENDED USE": "A remote controlled radionuclide applicator system is an\nelectromechanical or pneumatic device intended to enable\nan operator to apply, by remote control, a radionuclide\nsource into the body or to the surface of the body for\nradiation therapy.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Stationary radiation\nprotection barrier",
   "INTENDED USE": "A device for permanent installation that forms a structural\nbarrier that shields or attenuates radiation emitted from\nprimary radiation source or scattered radiation source.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Stereotactic\nradiotherapy\naccelerator system",
   "INTENDED USE": "A stereotactic radiation therapy system for treatment based\non a linear accelerator (or microtron). The device may be\nused to inactivate lymphocytes.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "X-ray CT system for\nradiotherapy planning",
   "INTENDED USE": "A X-ray CT system that has a special configuration,\ncontaining hardware, software, etc. used in radiotherapy\nplanning. It is used to determine the size and positioning of\nthe therapeutic radiation field based on a series of\ntreatment parameters to be generated.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "X-ray radiation therapy\nsystem",
   "INTENDED USE": "An x-ray radiation therapy system is a device intended to\nproduce and control x-rays used for radiation therapy.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "X-ray/CT combined\nlinear accelerator\nsystem",
   "INTENDED USE": "A combined system of a linear accelerator system and an X-\nray CT system for radiotherapy planning.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "X-ray/CT combined\nparticle radiotherapy\nequipment",
   "INTENDED USE": "A combined system of particle radiotherapy equipment and\nan X-ray CT system for radiotherapy planning.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Absorbable peritoneum\ncatheter cuff",
   "INTENDED USE": "Inteded to maintain stable contact between the skin and the\nperitoneal dialysis catheter, and prevents bacterial invasion\nfrom the outlet. It is embedded subcutaneously at the outlet of\nthe peritoneal dialysis catheter.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Automated peritoneal\ndialysis system",
   "INTENDED USE": "An active medical devices intended to perform peritoneal\ndialysis.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Urinary stone retrieval\nbasket",
   "INTENDED USE": "Intended to remove urinary stones ( renal calculi) from the\nbody during an endoscopic procedure.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Chair, Haemodialysis,\nElectrically\npowered/Manual.",
   "INTENDED USE": "Intended to support the patient in a seated or reclined posture\nduring haemodialysis procedures.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Collagen-containing\nperitoneum absorbable\ncatheter cuff",
   "INTENDED USE": "A cuff that consists of biodegradable porous material\ncontaining collagen, intended to be embedded subcutaneously\nat the outlet of the peritoneal dialysis catheter.",
   "RISK BASED CLASSIFICATION": "D"
 },
 {
   "MEDICAL DEVICE NAME": "Crimp for plier,\nHaemodialysis",
   "INTENDED USE": "Intended to manipulate the arteriovenous shunt of patients\nrequired hemodialysis.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Dialyser connector",
   "INTENDED USE": "Intended to connect between a dialysis fluid circuit and\ndialyzer, etc.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Hemodialysis blood\ntubing/Extracorporeal\nsystems for blood\npurification",
   "INTENDED USE": "Sterilized blood tubing intended for hemodialysis (including\nhemofiltration and hemodiafiltration).",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Hollow-fibre\nhaemodialysis dialyser",
   "INTENDED USE": "Hollow fiber filter intended to remove impurities/fluid from\nthe blood of a patient via haemodialysis machine.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Kidney donor-organ\npreservation/transport\nsystem",
   "INTENDED USE": "A dedicated system designed to support and maintain a\ndonated kidney organ during transport from the donor to the\nreceiver hospital where the organ will be transplanted into the\nrecipient.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Kidney stone filter",
   "INTENDED USE": "A filter intended to be placed in the urinary duct to prevent a\nrenal stone from moving from the kidney into the bladder.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Laser lithotripsy\nfibre/suction guide",
   "INTENDED USE": "Intended to function as a channel for insertion of the laser\nfibre of a laser beam guide (e.g., of a general/multiple surgical\nlaser system) in nephroscope, and for removal of debris (e.g.,\nfluid, calculi fragments) when connected to a vacuum source.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Multi-patient dialysis fluid\ndelivery system",
   "INTENDED USE": "Intended to prepares dialysis fluid for hemodialysis.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Peritoneal dialysis catheter\nadaptor",
   "INTENDED USE": "Intended to connect (devices of different makers and makes\ndevices compatible with each other) a catheter for peritoneal\nlavage to an external device that manages dialysates.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Extracorporeal circuit\nwaste bag",
   "INTENDED USE": "Intended to be used for the collection of waste fluids during\npreparation and processing of an extracorporeal circuit (e.g.,\nhaemodialysis, haemofiltration, apheresis, adsorption\ntreatment), including the collection and rinsing of ultrafiltrate\nfluid which may contain blood components.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Haemodialysis concentrate",
   "INTENDED USE": "Intended to remove metabolic waste from the blood to help\nmaintain physiological blood electrolyte and pH levels while\nhaemodilysis is performed.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Haemodialysis\nconductivity standard\nsolution",
   "INTENDED USE": "Intended to calibrate conductivity meters used to test the\nconductivity of dialysate, dialysate concentrate, and water\ntreatment systems used with haemodialysis delivery systems.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Haemodialysis dialysate\nwater chlorine test kit/strip",
   "INTENDED USE": "Intended to be used to rapidly indicate, through colour\nchange, the concentration of total chlorine in water used to\nprepare dialysate solution for haemodialysis.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Haemodialysis system\nair/foam detector",
   "INTENDED USE": "Intended to identify air bubbles and/or foam in blood returned\nto the body [usually through an arteriovenous fistula (AVF)]\nby the extracorporeal blood circuit of a haemodialysis system.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Haemodialysis system\nbicarbonate mixer",
   "INTENDED USE": "Intended to mixes two concentrates, A and B, plus water, to\nthe dialysis solution (dialysate) and monitors the mixture.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Continuous Glucose\nMonitor\nRetrospective Data\nAnalysis Software",
   "INTENDED USE": "Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate\nretrospective data from a continuous glucose monitoring device.",
   "RISK BASED CLASSIFICATION": "A"
 },
 {
   "MEDICAL DEVICE NAME": "Continuous Glucose\nMonitor Secondary\nDisplay",
   "INTENDED USE": "The purpose of the continuous glucose monitor secondary display is to notify another person, the\nfollower, of the patient's continuous glucosemonitoring system sensor glucose information in real time.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Insulin Pump\nSecondary Display",
   "INTENDED USE": "The purpose of the insulin pump secondary display is to notify another person of the patient's insulin\npump usage information in real time.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Insulin Pump\nTherapy\nAdjustment\nCalculator For\nHealthcare\nProfessionals",
   "INTENDED USE": "An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend\ninsulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin\nsensitivity factors) based on data from external devices, including continuous glucose monitors. The\ndevice is software with a graphical user interface.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Coronary Vascular\nPhysiologic\nSimulation Software",
   "INTENDED USE": "A coronary vascular physiologic simulation software device is intended to aid in the identification of\nfunctionally significant cardiovascular disease by performing offline analysis of pre-existing imaging data\nto simulate blood flow in the coronary vasculature.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Multivariate Vital\nSigns Index",
   "INTENDED USE": "Automated calculation of a summary index (or indices) based on several individual measured vital sign\ninputs. Collects measured parameter inputs and automates the calculation of a summary index based\non those parameters",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Electrocardiograph\nSoftware for home\nuse.",
   "INTENDED USE": "Device intended for home use which creates, analyzes, and displays electrocardiograph data, and can\nprovide information for identifying cardiac arrhythmias.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Photoplethysmogra\nph Analysis\nSoftware for home\nuse.",
   "INTENDED USE": "Photoplethysmograph analysis software device for home analyzes of photoplethysmograph data and\nprovides information for identifying irregular heart rhythms. This device is not intended to provide a\nclinical diagnosis.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Source Localization\nSoftware For\nElectroencephalogr\naph Or\nMagnetoencephalo\ngraph",
   "INTENDED USE": "Correlation of electrical activity of the brain using various neuroimaging modalities for source-\nlocalization",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Automatic Event\nDetection Software\nFor\nPolysomnograph\nWith\nElectroencephalogr\naph",
   "INTENDED USE": "Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification\nof such events and annotation of prolonged PSG traces; Automatically calculate simple measures\nobtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of\nmarked events); All output subject to verification by qualified clinical user",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Automatic Event\nDetection Software\nFor Full-Montage\nElectroencephalogr\naph",
   "INTENDED USE": "Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures,\nseizure-like events in order to aid in identification of such events and help review and annotation of\nprolonged EEG traces; All output subject to verification by qualified clinical user",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Computerized\nCognitive\nAssessment Aid For\nConcussion",
   "INTENDED USE": "For use as an assessment aid in the management of concussion.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "AtaxiagraphWith\nInterpretive\nSoftware",
   "INTENDED USE": "Device used to determine the extent of ataxia (failure of muscular coordination) by measuring the\namount of swaying of the body when the patient is standing erect and with eyes closed and provides\ninterpretation or clinical implication of themeasurement.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Computerized\nBehavioral Therapy\nDevice For\nPsychiatric\nDisorders",
   "INTENDED USE": "The device is intended to provide cognitive behavioral therapy to treat substance use disorder. The\ndevice is a software-based mobile app downloaded onto a smartphone.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Radiological\nComputer Assisted\nDetection/Diagnosis\nSoftware For\nLesions Suspicious\nFor Cancer",
   "INTENDED USE": "A radiological computer assisted detection and diagnostic software for suspected lesions is an image\nprocessing device intended to aid in the detection, localization, and characterization of lesions\nsuspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound,\nradiography).",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "X-Ray Angiographic\nImaging Based\nCoronary Vascular\nSimulation Software\nDevice",
   "INTENDED USE": "X-ray angiographic imaging based coronary vascular simulation software device is a device that\nprovides an image analysis tool to assess blood flow in the coronary vascular system using X-ray\nangiographic imaging data. And yields simulation-based metrics for certain cardiology applications\nwhich aid clinical user.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Automated\nRadiological Image\nProcessing Software",
   "INTENDED USE": "To provide automated radiological image processing and artificial intelligence based analysis tools.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Image Acquisition\nAnd/Or\nOptimization\nGuided By Artificial\nIntelligence",
   "INTENDED USE": "A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the\nacquisition and/or optimization of images and/or diagnostic signals.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Burn Resuscitation\nDecision Support\nSoftware",
   "INTENDED USE": "The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid\nvolume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than\n20% total body surface area burn.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Software, Similarity\nScore Algorithm,\nTissue Of Origin For\nMalignant Tumor\nTypes",
   "INTENDED USE": "This test is intended to measure the degree of similarity between the RNA expression pattern in a\npatient?s fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some\ncommonmalignant tumor types that were diagnosed according to then current clinical and pathological\npractice.",
   "RISK BASED CLASSIFICATION": "C"
 },
 {
   "MEDICAL DEVICE NAME": "Software for public\nthoracic and\nabdominal health\nscreening\ndiagnostic X-ray\nsystem",
   "INTENDED USE": "A software, which is designed to process data obtained from a thoracic and abdominal public health\nscreening diagnostic X-ray system. The resultant data are provided for diagnosis, etc. This term may\ninvolve the recording media where the software are stored.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Software for visual\nevoked response\nstimulator",
   "INTENDED USE": "A software, which is designed to process data obtained from a visual evoked response stimulator. The\nresultant data are provided for diagnosis, etc.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Software for\nauditory evoked\nresponse stimulator",
   "INTENDED USE": "A software for medical device, which is designed to process data obtained from an auditory evoked\nresponse stimulator. The resultant data are provided for diagnosis, etc.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Software for\npulmonary exercise\nstress monitoring\nsystem",
   "INTENDED USE": "A software, which is designed to process data obtained from a pulmonary exercise stress monitoring\nsystem.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Software for ECG\nrecorder with real-\ntime analysis",
   "INTENDED USE": "A software, which is designed to process data obtained from an ECG recorder with real-time analysis.\nThe resultant data are provided for diagnosis, etc.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Software for film-\nrecorded digital\nradiography",
   "INTENDED USE": "A software, which is designed to process data obtained from a film-recorded digital radiography. The\nresultant data are provided for diagnosis, etc.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Software for dye\ndilution cardiac\noutput calculator",
   "INTENDED USE": "A software, which is designed to process data obtained from a dye dilution cardiac output unit. The\nresultant data are provided for diagnosis, etc.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Software for\nurodynamic\nmeasurement\nsystem",
   "INTENDED USE": "A software, which is designed to process data obtained from a urodynamic measurement system. The\nresultant data are provided for diagnosis, etc.",
   "RISK BASED CLASSIFICATION": "B"
 },
 {
   "MEDICAL DEVICE NAME": "Software for\nvestibular function\ncaloric stimulator",
   "INTENDED USE": "A software, which is designed to process data obtained from a vestibular function caloric stimulator. The\nresultant data are provided for diagnosis, etc.",
   "RISK BASED CLASSIFICATION": "B"
 }
];

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