261 lines
42 KiB
HTML
261 lines
42 KiB
HTML
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.footer {
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position: fixed;
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bottom: 0;
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width: 100%;
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background-color: purple;
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color: white;
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text-align: center;
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font-style: times roman;
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font-weight:40;
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background-size: 30;
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<style>
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.header {
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text-align: center;
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color: white;
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background-color: purple;
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backface-visibility: bold;
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font-style: arial;
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font-weight: 36;
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text-align: center;
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<body>
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<div class="container" style="margin:10px auto">
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<table id="datatable" class="table table-striped table-hover">
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<div class="header">
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<h2>CDSCO LIST OF MEDICAL DEVICE TESTING LABORATORY</h2>
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</div>
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<div class="footer">
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<p>Spoorthi S Supported By Shanmukha Innovations Private Limited</p>
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<a>https://www.g20.org/en/</a>
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</div>
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<thead>
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<tr>
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<th>SL_NO</th>
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<th>Name and Address of the Testing Laboratory</th>
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<th>Registration Number</th>
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<th>Scope Of Testing</th>
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</tr>
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</thead>
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</table>
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</div>
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<script>
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const data = [
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{
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"SL_NO": 1,
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"Name and Address of the Testing Laboratory": "M/s SIPRA LABS LIMITED\r\nAddress: 7-2-1813/5/A. Adj. To Post Office, Industrial Estate, Sanathnagar, Telangana, Hyderabad- 500018",
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"Registration Number": "TL/MD/2019/000001",
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"Scope Of Testing": "1. Copper -T \r\n2.Condoms \r\n3.Sterile Hypodermic Needles \r\n4.Tubal Rings\r\n5.Hypodermic Syringes\r\n6.Blood Bags",
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},
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{
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"SL_NO": 2,
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"Name and Address of the Testing Laboratory": "M/s Star Imaging &\r\nPath Lab Pvt. Ltd.\r\nAddress: 4B/4, Tilak\r\nNagar, West Delhi, \r\nDelhi (India) -110018\r\n\r\n",
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"Registration Number": "TL/MD/2019/000002",
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"Scope Of Testing": "1. Bilirubin (Total and Direct)Test Reagents / Kits\r\n2. Creatinine test reagent / kit\r\n3. Aspartate Amino Transferase (AST /SGOT) test\r\n4.AlanineAminoTransferase (ALT/SGP)test\r\n5. Uric Acid Test reagents / kits\r\n6. Total Protein test reagents / kits\r\n7. Activated partial thromboplastin time(APTT) test\r\n8. PT (Prothrombin Time) Test reagents / Kits",
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},
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{
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"SL_NO": 3,
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"Name and Address of the Testing Laboratory": "M/s Alcatec\r\nResearch Laboratories India Pvt. Ltd.\r\nAddress:1652,MIE \r\nPart B, Bahadurgarh, \r\nHaryana-124507\r\n",
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"Registration Number": "TL/MD/2019/000003",
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"Scope Of Testing": "1. Sterilized Surgical Ligatures\r\n2.Sterilized Disposable Device\r\n3.Sterilized Surgical Sutures"
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},
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{
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"SL_NO": 4,
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"Name and Address of the Testing Laboratory": "M/s Sree Chitra\r\nTirunal Institute Form Medical Sciences & Technology\r\nAddress: Medical\r\nCollege,\r\nThiruvananthapuram, Kerala - 695011\r\n",
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"Registration Number": " TL/MD/2019/000004",
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"Scope Of Testing": "1.Cardio Vascular Devices (Biological Evaluation as per ISO 10993)\r\n2. Neuroprosthesis (BiologicalEvaluation as per ISO 10993)\r\n3.0rthopedic Implants (BiologicalEvaluation as per ISO 10993)\r\n4 All medical devices and Materials(Biological Evaluation as per ISO 10993)\r\n5.Dental Implants (Biological Evaluation as per ISO 10993)"
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},
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{
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"SL_NO": 5,
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"Name and Address of the Testing Laboratory": "M/s, GLR\r\nLaboratories Private Limited\r\nAddress:GOKULAM STREET, Mathur,\r\nMATHUR,Chennai, \r\nTamil Nadu - 600068\r\n",
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"Registration Number": " TL/MD/2019/000005",
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"Scope Of Testing": "1 Cardiovascular devices (Biological evaluation as per ISO 10993) \r\n2. Orthopaedic devices (Biological evaluation as per ISO 10993) \r\n3. Ocular devices (Biological evaluationas per ISO 10993)\r\n4. Surgical devices and sutures (Biological evaluation as per ISO 10993)\r\n5. Respiratory devices (Biological evaluation as per ISO 10993)\r\n6. Gastrointestinal devices (Biological evaluation as per ISO 10993)\r\n7. Urological devices (Biological evaluation as per ISO 10993)\r\n8. Haematological devices and IV sets (Biological evaluation as per ISO10993)\r\n9. Dental devices (Biological evaluation as per ISO 10993)\r\n10. Personal care products and family planning (Biological evaluation asper ISO 10993)\r\n11. Neurological devices (Biological evaluation as per ISO 10993)\r\n12.All medical devices and Materials(Biological evaluation as per ISO 10993)\r\n"
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},
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{
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"SL_NO": 6,
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"Name and Address of the Testing Laboratory": "M/s, PALAMUR\r\nBIOSCIENCES \r\nPRIVATE LIMITED\r\nAddress: 401 Aikya, \r\n4th Floor, H.No-10-3-3219/23, Opp. Faust High School, East Marredpally,\r\nSecunderabad, \r\nHyderabad,\r\nTelangana-500026\r\n",
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"Registration Number": " TL/MD/2019/000006",
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"Scope Of Testing": "1. Catheters (Biological Toxicity)\r\n2. Disposable Hypodermic needles\r\n(Biological Toxicity)\r\n3. Surgical dressings (Biological Toxicity)\r\n4.Orthopaedic Implants(Biological Toxicity)\r\n5.Blood Bags (Biological Toxicity)\r\n6. Drug eluting stent(Biological Toxicity)\r\n7.Intra Ocular Lenses (Biological Toxicity)\r\n8. Sutures (Biological Toxicity)\r\n9. Condoms (Biological Toxicity)\r\n10. Heart Valves (Biological Toxicity)\r\n11. Disposable perfusion sets (Biological Toxicity)\r\n12. Cardiac stent (Biological Toxicity)\r\n13. Copper- T (Biological Toxicity)\r\n14. Scalp Vein Set (Biological Toxicity)\r\n"
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},
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{
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"SL_NO": 7,
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"Name and Address of the Testing Laboratory": "M/s,Eurofins \r\nAdvinus Limited\r\nAddress: 21 & 22, \r\nPhaseII,Peenya \r\nIndustrial Area, Bengaluru\r\nPincode:560058, INDIA,Bangalore, Bengaluru\r\n(Bangalore)Urban, \r\nKarnataka - 560058\r\n",
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"Registration Number": "\r\n\r\n\r\n\r\n\r\n TL/MD/2020/000001\r\n",
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"Scope Of Testing": "1. Disposable Perfusion Sets\r\n2. Cardiac Stents\r\n3. Drug Eluting Stents\r\n4. Blood Bags\r\n5. Catheters (Class D)\r\n6. Catheters (Class B)\r\n7. Catheters (Class C)\r\n8. Heart valves\r\n9. Intra Ocular Lenses\r\n10.I.V. Cannula\r\n11. Bone Cements\r\n12. Internal Prosthetic Replacements\r\n13. Peritoneal dialysis sets\r\n14. Condoms\r\n15.Intra-uterine devices\r\n16. Surgical dressing\r\n17. Scalp Vein Set\r\n18. Ligatures and sutures"
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},
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{
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"SL_NO": 8,
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"Name and Address of the Testing Laboratory": "M/s,TRUSTIN \r\nANALYTICAL \r\nSOLUTIONS\r\nPRIVATE LIMITED\r\nAddress: Plot no-\r\n303/b, Block-B, \r\nRK Complex, 1st\r\nFloor,Thiruneermalai road,Parvathy puram, Chrompet,\r\nChennai,Kanchipuram, Tamil Nadu - 600044\r\n",
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"Registration Number": " TL/MD/2020/000002",
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"Scope Of Testing": "1. Disinfectant ( Sterility and Antimicrobial activities as per ISO 11737-1 and 2, USP42, EP 9.0, IP 2018, BP 2018)\r\n 2. Catheters (Sterility, Bioburden and BET as per ISO 11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018) - Class A \r\n3. Surgical Sutures (Physical parameters, Sterility and BET as per ISO 11737-2, USP42, EP 9.0, IP 2018, BP 2018) -Class B\r\n4. Surgical Dressings ( Sterility ,Bioburden, BET as per IS 758, IS 1954, ISO 11737-land 2, IP 2018, USP 42, BP 2018 and EN9.0) -Class A\r\n5. Surgical Dressings ( Sterility,Bioburden, BET as per IS 758. IS 1954.1SO 11737-land 2, IP 2018, USP 42, BP 2018 and EN9.0) -Class B\r\n6. Surgical Dressings ( Sterility,Bioburden, BET as per IS 758, IS 1954, ISO 11737-land 2, IP 2018, USP 42, BP 2018 and EN9.0) -Class C\r\n7. Surgical Dressings ( Sterility,Bioburden, BET as per IS 758, IS 1954, ISO 11737-land 2, IP 2018. USP 42. BP 2018 and EN9.0) -Class D\r\n8. Blood bags with and without anticoagulant solutions (Mechanical, Sterility and BET as per ISO 3826, IS 15102, ISO 11737-2. USP42. EP 9.0.1P 2018, BP 2018)\r\n9. Contraceptives (Condoms -Male/Female Condoms) (Mechanical parameters,Bioburden and Pathogens as per ISO 4074-2015, VVHOUNAIDS2010, IS025841-2017,WHOUNAIDS2012,Schedule R, 15011737-1, IP 2018, USP42\r\n10. Catheters (Sterility, Bioburden and BET as per ISO 11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018) - Class B\r\n11.Catheters (Sterility, Bioburden and BET as per ISO 11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018) - Class C\r\n12. Disposable Hypodermic Needles (Sterility, Bioburden and BET as per ISO 11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018) - Class C\r\n13. Disposable Perfusion sets (Physical testing, Sterility, Bioburden and BET as per ISO 1135-Part 4, IS 9824-3, ISO 11737-1 and 2, USP 42, EP 9.0,IP 2018, BP 2018) - Class B\r\n14. Disposable Perfusion sets (Physical testing , Sterility, Bioburden and BETas per ISO 1135-Part 4, IS 9824-3, ISO 11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018) - Class C\r\n15. Intraocular Lenses (Sterility,Bioburden, BET and Pathogen identification as per ISO 11737 -Part 1 and 2, USP 42, EP 9.0, IP 2018, BP 2018)\r\n16. Orthopaedic Implants (Sterility, Bioburden and BET as per ISO 11737-1 and2, USP 42, EP 9.0, IP 2018, BP 2018) - Class C\r\n17. Orthopaedic Implants ( (Sterility,Bioburden and BET as per ISO11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018) - Class D\r\n18. Cardiac Stents ( Sterility test as per IS011737-2, USP 42, EP 9.0, IP 2018, BP2018)- Class C\r\n19. Cardiac Stents ( Sterility test as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP2018) - Class D\r\n20. Contraceptives (CuT) (Mechanical parameters, Sterility. Bioburden as perWHO UNFPA 2016, ISO 7439; ISO 11737-land 2, IP 2018, USP 42, BP 2018, EP 9.0)\r\n21. Disposable Hypodermic Syringes(Sterility and BET as per ISO 11737-2; USP 42; EP9.0; IP 2018, BP 2018) - Class B\r\n22. Catheters (Sterility, Bioburden and BET as per ISO 11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018) - Class D\r\n23 .DisposableHypodermicNeedles(Sterility,Bioburden and BET as per ISO 11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018) - Class B\r\n24. Disposable Perfusion sets (Physical testing, Sterility, Bioburden and BET as per ISO 1135-Part 4, IS 9824-3, ISO 11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018) - Class A\r\n25. Disposable Perfusion sets (Physical testing; Sterility, Bioburden and BET as per ISO 1135-Part 4, IS 9824-3, ISO 11737-1 and 2, USP 42, EP 9.0,IP 2018, BP 2018) - Class C\r\n26. Intraocular Lenses (Sterility,Bioburden, BET and Pathogen identification as per ISO 11737 -Part 1 and 2, USP 42, EP9.0, IP 2018, BP 2018)\r\n27. Internal Prosthetic Replacements (Sterility test as per ISO 11737-2. USP 42,EP 9.0, IP 2018, BP 2018)\r\n28. Heart Valves (Sterility test as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018)\r\n29. Surgical Sutures (Physicalparameters, Sterility and BET as per ISO 11737-2, USP 42, EP 9 0 IP 2018, BP 2018) - Class A\r\n30. Surgical Sutures (Physicalparameters, Sterility and BET as per ISO 11737-2, USP 42, EP 9 0 IP 2018, BP 2018) - Class C\r\n31. Contraceptives (TubalRing)(Mechanical parameters and Sterility as per IS 13009-2000. ISO 11737-2, USP 42, EP 9.0, IP2018, BP 2018)\r\n32. Disposable Perfusion sets (Physical testing, Sterility, Bioburden and BET as per ISO 1135-Part 4, IS 9824-3, ISO 11737-1 and 2, USP 42. EP 9.0, IP 2018, BP 2018)-Class B\r\n33. Internal Prosthetic Replacements (Sterility test as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018) 1\r\n34 IV Cannulae (Sterility, Bioburden.Pathogen identification as per ISO 11737-land 2, USP 42, EP 9.0. IP 2018 :BP 2018)\r\n35. Disposable Hypodermic Syringes(Sterility and BET as per ISO 11737-2, USP 42, EP9.0, IP 2018, BP 2018)"
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},
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{
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"SL_NO": 9,
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"Name and Address of the Testing Laboratory": "M/s, Devansh\r\nTesting & Research \r\nLaboratory Pvt. Ltd.\r\nAddress: RZ-21A/331, \r\nMadanpuri, Gali No.-\r\n10, West Sagar Pur,Delhi, West Delhi, \r\nDelhi -110046\r\n \r\n",
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"Registration Number": "TL/MD/2020/000003 ",
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"Scope Of Testing": "1. Catheters Class A\r\n2. Catheters (Excluding Bio-compatibility testing) - Class B \r\n3. Catheters (Excluding Bio-compatibility testing)- Class C\r\n 4. Disposable Perfusion Sets (Excluding Biocompatibility testing) -Class C\r\n5. Disposable Hypodermic Needles(Excluding Bio-compatibility testing)- Class C\r\n6.Disposable Hypodermic Needles (Excluding Bio-compatibility testing)- Class D\r\n7.Disposable Hypodermic Syringes -Class A\r\n8. Disposable Hypodermic Syringes(Excluding Bio-compatibility testing)- Class B\r\n9. Disposable Hypodermic Syringes(Excluding Bio-compatibility testing)- Class C\r\n10. Disposable Hypodermic Syringes (Excluding Bio-compatibility testing)- Class D\r\n11. I.V. Cannulae - Class A\r\n12. I.V. Cannulae (Excluding Bio-compatibility testing) - Class B\r\n13. I.V. Cannulae (Excluding Bio-compatibility testing) - Class C\r\n14. I.V. Cannulae (Excluding Bio-compatibility testing) - Class D\r\n15. Scalp Vein Set - Class A\r\n16. Scalp Vein Set (Excluding Biocompatibility testing) - Class B\r\n17. Scalp Vein Set (Excluding Biocompatibility testing) - Class C\r\n18. Scalp Vein Set (Excluding Biocompatibility testing) - Class D\r\n19. Surgical Dressings - Class A\r\n20. Surgical Dressings (Excluding Biocompatibility testing) - Class B\r\n21. Surgical Dressings (Excluding Biocompatibility testing) - Class C\r\n22. Surgical Dressings (Excluding Biocompatibility testing) - Class D\r\n23. Contraceptives - Class A\r\n24. Contraceptives (Excluding Biocompatibility testing) - Class B\r\n25. Contraceptives (Excluding Biocompatibility testing) - Class C\r\n26. Contraceptives (Excluding Biocompatibility testing) - Class D\r\n27. Disinfectant - Class A\r\n28. Catheters (Excluding Bio-compatibility testing- Class D\r\n29. Disposable Hypodermic Needles -Class A\r\n30. Disposable Hypodermic Needles(Excluding Bio-compatibility testing)- Class B\r\n31. Disinfectant (Excluding Bio-compatibility testing) - Class B\r\n32. Disinfectant (Excluding Bio-compatibility testing) - Class C\r\n33. Disinfectant (Excluding Bio-compatibility testing) - Class D\r\n34. Disposable Perfusion Sets - Class A\r\n35.Disposable Perfusion Sets(Excluding Bio-Compatability Testing)-Class B\r\n36.Disposable Perfusion Sets(Excluding Bio-Compatability)"
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},
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{
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"SL_NO": 10,
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"Name and Address of the Testing Laboratory": "M/s, JAGDAMBA\r\nLABORATORI ES\r\nAddress: 119, \r\nSolitaire Industrial \r\nPark, Phase-1,\r\nDahmikallan, Bagru, \r\nJaipur, Rajasthan-\r\n303007\r\n\r\n",
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"Registration Number": "TL/MD/2020/000004",
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"Scope Of Testing": "1. Catheters (Test as per IS/ISO 10555) - Class A\r\n2. Disinfectants (As per IP, BP, USP) -Class B\r\n3. Disposable Hypodermic Needles (Test as per IS 10654) - Class B \r\n4. Disposable Perfusion Sets (Test asper IS 12655) - Class A\r\n5. Disposable Perfusion Sets (Test as per IS 12655) - Class B\r\n6. Catheters (Test as per IS/ISO 10555)- Class B\r\n7. I.V. Cannulae (Test as per IS/ISO 10555) - Class B\r\n8. Disposable Hypodermic Syringes(Test as per IS10258) - Class B \r\n9. Scalp vein set (Test as per IS 16097)- Class B\r\n10. Surgical Dressings (Cotton and Gauze, Bandage)-Class B\r\n11. Surgical Dressings (Cotton and Gauze, Bandage)-Class A"
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},
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{
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"SL_NO": 11,
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"Name and Address of the Testing Laboratory": "ITL LABS PVT LTD\r\nB-283-284,\r\nMangolpuri Industrial Area, Phase I, North West Delhi,\r\nDelhi -110083 ",
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"Registration Number": "\r\nTL/MD/2021/000001",
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"Scope Of Testing": "1 Catheters (Excluding Bio-compatibility testing) Class D\r\n2. Surgical Dressings (ExcludingBiocompatibility testing) class D \r\n3. Disposable Hypodermic Syringes Class D\r\n4. Disposable Hypodermic Syringes(Excluding Bio-compatibility testing) Class D\r\n 5.Surgical Dressings Class D\r\n6.Disposable Hypodermic Needles(Excluding Bio-compatibility testing)\r\nClass C\r\n7.Contraceptives Class D\r\n8.I.V. Cannulae (Excluding Bio-compatibility testing) Class C \r\n9. Surgical Dressings (Excluding Biocompatibility testing)Class D\r\n10. Scalp Vein Set (ExcludingBiocompatibility testing) Class B\r\n11. Disposable Hypodermic Needles Class C\r\n12. 1.V. Cannulae Class C\r\n13. I.V. Cannulae (Excluding Bio-compatibility testing) Class C\r\n14. Scalp Vein Set Class B\r\n15. Contraceptives (ExcludingBiocompatibility testing) Class D\r\n16. Catheters Class D\r\n17. Disinfectant Class B\r\n18. Disposable Perfusion Sets (Excluding Biocompatibility testing) Class C\r\n19. Disinfectant (Excluding Bio-compatibility testing) Class B\r\n20. Disposable Perfusion Sets Class C\r\n21. Disposable Perfusion Sets (Excluding Biocompatibility testing) Class C\r\n22. Disposable Hypodermic Needles(Excluding Bio-compatibility testing) Class D\r\n23. Surgical Suture Class D\r\n24. Urine collecting bag Class B\r\n25. Surgical Gloves ( Sterile/Non Sterile) Class D\r\n26. Endotracheal (ET) tube class B\r\n27 Disposable Hypodermic Syringes Class C\r\n28. Blood Bag (Single Blood Bag,Double Blood Bag, Triple Blood Bag, Quad Blood Bag) Class C\r\n29.Disinfectant(Excluding Bio-Compatibility testing)"
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},
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{
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"SL_NO": 12,
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"Name and Address of the Testing Laboratory": "Accuprec Research\r\nLabs Private Limited\r\nOpp Zydus Pharmez, \r\nChangodar- Bavla Highway, \r\nVill-Matoda„ Sanand, Ahmedabad, \r\nGujarat - 382213\r\n",
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"Registration Number": "TL/MD/2021/000002",
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"Scope Of Testing": "1. Vascular devices and IV sets; Class\r\n2 Tubal rings; Class C\r\n3. Copper T; Class C\r\n4.Sutures; Class C\r\n5. Disposable Hypodermic needles; Class C\r\n6. Catheters; Class D\r\n7. Disposable Hypodermic Syringes; Class B\r\n8. Blood bags; Class B\r\n9. Condoms; Class C\r\n10. Coronary stents; Class D\r\n11. Intra Ocular Lenses Implants; Class D\r\n12.Orthopaedic Implants and Devices; Class D\r\n13. Drug eluting stents; Class D\r\n14. Internal Prosthetic replacements;Class D\r\n15. Ablation devices; Class D"
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},
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{
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"SL_NO": 13,
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"Name and Address of the Testing Laboratory": "M/s, Conformity\r\nTesting Labs Pvt Ltd\r\nWH-52, Mayapuri \r\n\tIndustrial Area, Phase \r\n\t1, New Delhi, West \r\n\tDelhi, Delhi -110064 ",
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"Registration Number": "TL/MD/2021/000003",
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"Scope Of Testing": "1.NIBP; Class B\r\n2.IBP; Class C\r\n3. Nebulizer; Class C\r\n4.Thermometer; Class B\r\n5.Glucometer; Class B"
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},
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{
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"SL_NO": 14,
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"Name and Address of the Testing Laboratory": "Brothers Laboratories Pvt. Ltd\r\n103, D-3, Industrial \r\nArea Jhotwara, Jaipur, \r\nRajasthan - 302012\r\n\r\n",
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"Registration Number": "TL/MD/2021/000004",
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"Scope Of Testing": "1. Disposable Hypodermic Needles; Class B\r\n2. Surgical Dressings; Class A\r\n3. Disposable perfusion set; class B\r\n4. Catheters; Class B\r\n5.Surgical Dressings; Class B\r\n6.Disinfectants; Class B\r\n7. Disposable Hypodermic Syringe; Class B\r\n8.IV Canulae; Class B\r\n9.Scalp Vein Set; Class B"
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},
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{
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"SL_NO": 15,
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"Name and Address of the Testing Laboratory": "M/s, ShivaAnalyticals (India) Private Limited\r\nSituated at Plot Nos. 24D (P) & 34D,\r\nKIADB Industrial Area,Hoskote,Bangalore, Hoskote, Bengaluru(Bangalore) Rural, \r\nKarnataka - 562114",
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"Registration Number": "TL/MD/2021/000005",
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"Scope Of Testing": "1. Cardiac Stents (Test- Ethylene Oxide residue,Standard/Specification-ISO 10993-7-2008) Class C, Class D\r\n2. Catheters (Test- Ethylene Oxide residue, Standard/Specification-ISO 10993-7-2008) Class A, B, C, D\r\n3. Disposable Perfusion Sets (Test-Ethylene Oxide residue,Standard/Specification-ISO 10993-7- 2008) Class A, Class B,Class C\r\n4. Drug Eluting Stents (Test- EthyleneOxide residue,Standard/Specification-ISO-10993-7-2008) Class D\r\n5. Heart Valves (Test- Ethylene Oxide residue, Standard/Specification-ISO 10993-7-2008) Class D\r\n6. Intra Ocular Lenses (Test- Ethylene Oxideresidue,Standard/Specification-ISO 10993-7-2008) Class C\r\n7. IV Cannula (Test- Ethylene Oxideresidue, Standard/Specification-ISO 10993-7-2008) Class B, Class C\r\n8. Orthopaedic Implants(Test-Ethylene Oxideresidue,Standard/Specification-ISO 10993-7-2008) Class B, Class C, Class D.\r\n9. Scalp Vein Set (Test- Ethylene Oxide residue,standard/Specification-ISO 10993-7-2008) Class B\r\n10. Surgical Dressings (Test- Ethylene Oxide residue,Standard/Specification-ISO 10993-7- 2008) Class A, Class B, Class C, Class D\r\n11. Disposable Hypodermic Needles(Test-Ethylene Oxide residue,Standard/Specification-ISO 10993-7-2008) Class B\r\n12. Disposable Hypodermic Syringes Test-Ethylene Oxide residue, Standard/Specification-ISO 10993-7-2008) Class B, Class C\r\n13. Ablation Device (Test- Ethylene Oxide residue,Standard/Specification-ISO-10993-7-2008)"
|
|
},
|
|
{
|
|
"SL_NO": 16,
|
|
"Name and Address of the Testing Laboratory": "Mis, APEX QUALITY\r\nCERTIFICATION \r\nSERVICES PVT. LTD.\r\nsituated \tat \t161, \r\nKASTURBA NAGAR,\r\nN IRMAN \tNAGAR,\r\nJaipur, \tJaipur, Rajasthan - 302019",
|
|
"Registration Number": "TL/MD/2021/000006 ",
|
|
"Scope Of Testing": "1. Infusion/Syringe Pump ( Flow Rate,Volume, Occlusion Pressure,Electrical Safety)(Reference Standard IEC 60601-2-24,IS13450(Part2 Sec24)and IEC 60601-1). Class C.\r\n2. Aspirator ( Vacuum Testing, Electrical Safety) (Reference Standard ISO 10079-1 and IEC 60601-1)Class C.\r\n3. Glucometer (Glucose Concentration Testing) (Reference Standard IS/ISO 15197.2013) Class C\r\n4. Blood Pressure Monitoring Devices (Leak Test. NIBP Pressure Accuracy) (Reference Standard IEC60601-2-30. 2009) Class B.\r\n 5. Nebulizer (Flow Rate, Aerosol Output, Aerosol Output Rate, Electrical Safety) (Reference Standard IS027427.2013 and IEC 60601-1) Class C.\r\n6. Digital Thermometer,\t(TemperatureTesting)\t(Reference Standard -IS/ISO 80601-2-56. 2017 and IS 3055 Part 1 and Part 2 and IS 6274)"
|
|
},
|
|
{
|
|
"SL_NO": 17,
|
|
"Name and Address of the Testing Laboratory": "M/s, Shri RamScientific And\r\nIndustrial Research Foundation\r\nAddress: 8E, Diamond Press Building,\r\nJhandewalan Extension, RaniJhansi Road,, Delhi, New Delhi, Delhi -110055\r\n \r\n\r\n",
|
|
"Registration Number": "TL/MD/2021/000007 ",
|
|
"Scope Of Testing": "1.Tubal Rings/Fallopian Rings (Shape. Dimensions, Fracture Test, Memory Test. Friction Force Test, Fatigue Test, Radio Opacity, Sterility, Identification of polymer) \r\n2.Male Latex Condoms (Dimensions, Burst volume and pressure test,Water Leakage test, Quantity of lubricant, Colour Fastness, Integrity of individual package seal,Labeling packaging and storage) \r\n3.COPPER-T 380A (PhysicalParameters and Dimensions, Pouch burst strength, Amt ofcopper wire, Strength of the Tie, Copper collar pull force, Sterility) \r\n4.Implantable Medical Devices(Physical Parameters and Dimensions, Sterility Test, BET Test, Bio-Burden Test)\r\n5.Implantable Medical Devices (Physical Parameters and Dimensions, Sterility Test, BET Test, Bio-Burden Test)\r\n6.IUCD-375 (Visual Inspection, Sealed Pouch peel strength, Frame dimensions, Copper wire weight, Insertion Tube dimension, Thread, Flange displacement force, Sterility)\r\n7.Disposable Hypodermic Needles (Acidity or Alkalinity, Extractable Metals, Physical Parameters and Dimensions, Performance Bond -Hub and Needle tube, Patency of lumen, Sterility, BacterialEndotoxin) \r\n8.Disposable syringe (Extraneous matter, Acidity or Alkalinity,Extractable Metals Lubricant, Physical Parameters and Dimensions, Sterility Test, Bacterial Endotoxin)\r\n9 Disposable syringe (Extraneousmatter, Acidity or Alkalinity,Extractable Metals Lubricant, Physical Parameters andDimensions, Sterility Test, Bacterial Endotoxin)\r\n10. Surgical dressings (Threads,weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)\r\n11. Surgical dressings (Threads,weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)\r\n12. Surgical dressings (Threads,weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)\r\n13. Sterile Hypodermic Syringe forSingle use (Sterility Test, Bacterial Endotoxin Test)\r\n14. Cardiac Stent (Sterility Test)\r\n15. Cardiac Stent (Sterility Test)\r\n16. Catheters (Dimensions, Sterility Test)\r\n17. Catheters (Dimensions, Sterility Test)\r\n18. Blood Bags (Sterility Test, BET,Chemical Analysis, Physical Dimensions)\r\n19. Blood Bags (Sterility Test, BET, Chemical Analysis, Physical Dimensions)\r\n20. Disposable Hypodermic Needles (Acidity or Alkalinity, Extractable Metals, Physical Parameters and Dimensions, Performance Bond -Hub and Needle tube, Patency of lumen, Sterility, BacterialEndotoxin)\r\n21. Surgical dressings (Threads,weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)\r\n22. Umbilical Tapes (Physical Test,Adhesive, Strength, Length dia)\r\n23. Umbilical Tapes (Physical Test. Adhesive, Strength, Length dia)\r\n24. IV Cannula (Dimensions, Sterility)\r\n25. IV Cannula (Dimensions, Sterility)\r\n26. Copper-T (Sterility Test, Membrane Filtration Method)\r\n27. Suture absorbable / Suture non-absorbable Synthetic (Sterility Test. Direct Inoculation Method)\r\n28. Tubal Ring (Sterility Test,Membrane Filtration Method)"
|
|
},
|
|
{
|
|
"SL_NO": 18,
|
|
"Name and Address of the Testing Laboratory": "M/s, VIVO BIO TECH LTD\r\nAddress: 3 Floor, Ilyas Mohammed KhanEstate, D. No. 8-2-672/ 5 & 6, Road No.1, Banjara Hills, Hyderabad,\r\nTelangana - 500034",
|
|
"Registration Number": "TL/MD/2021/000008",
|
|
"Scope Of Testing": "1. Infusion Set Class B\r\n2. Sutures Class\r\n3. Transcatheter Aortic Valve Class D\r\n4. Tubal Ring Class C\r\n5. Blood Collection Sets Class D\r\n6. Blood Bags Class\r\n7. Intraocular Lens Class C\r\n8. Orthopedic Implants Class"
|
|
},
|
|
{
|
|
"SL_NO": 19,
|
|
"Name and Address of the Testing Laboratory": "M/s, ConformityTesting Labs Pvt Ltd\r\nAddress: WH-52, Mayapuri Industrial\r\nArea, Phase 1, New Delhi, West Delhi, \r\nDelhi -110064",
|
|
"Registration Number": "TL/MD/2021/000009",
|
|
"Scope Of Testing": "1. CT scan Equipment\r\n2. MRI Equipment\r\n3. Defibrillators\r\n4. Bone Marrow cell separator\r\n5. PET Equipment\r\n6. X-Ray Equipment\r\n7. Dialysis Machine"
|
|
},
|
|
{
|
|
"SL_NO": 20,
|
|
"Name and Address of the Testing Laboratory": "M/s, Oasis TestHouse Limited\r\nsituated at SP-2, 22 Godam Industrial Estate, Jaipur-302006. Jaipur, Rajasthan -\r\n302006",
|
|
"Registration Number": "TL/MD/2022/000001",
|
|
"Scope Of Testing": "1. Orthopaedic Implants\r\n2. Intraocular lens\r\n3. Catheter class A \r\n4. Bone cement\r\n5. Blood bags\r\n6. Catheter Class B\r\n7. Disposable Hypodermic Needles\r\n8. Disposable Perfusion Sets\r\n9. Disposable Hypodermic Syringes\r\n10. IV Cannulae\r\n11. Scalp Ven Set\r\n12. surgical dressings\r\n13. Sutures and Ligatures\r\n14. Intrauterine Device"
|
|
},
|
|
{
|
|
"SL_NO": 21,
|
|
"Name and Address of the Testing Laboratory": "M/s, Oasis Test House\r\nituated at 24 A - B, Sardar Patel Industrial Estate. Narol,Ahmedabad, Gujarat- 382405",
|
|
"Registration Number": "TL/MD/2022/000003",
|
|
"Scope Of Testing": "1. Catheters - Class A\r\n2. Infra Ocular Lenses - Class C\r\n3. Orthopedic Implants -Class C\r\n4. Surgical Dressings - Class B\r\n5. Orthopedic Implants - Class D\r\n6. Scalp vein set - Class B\r\n7. Disinfectants - Class B\r\n8. Infusion sets - Class B \r\n9. Blood bags - Class C\r\n10. Catheters - Class B\r\n11. Disp Hypodermic Needles-Class B\r\n12. Disposable Perfusion Sets-Class B\r\n13. Disp Hypodermic Syringes-Class B\r\n14. Disposable Perfusion Sets- class A\r\n15. IV Cannulae - Class B\r\n \r\n \r\n\r\n"
|
|
},
|
|
{
|
|
"SL_NO": 22,
|
|
"Name and Address of the Testing Laboratory": "M/s Astute Labs Pvt.Ltd.,\r\nSr No. 82/1, Bajirao Dhawade Patil\r\nIndustrial Estate, NDA Road, Shivane. Pune, Maharashtra - 411023\r\n",
|
|
"Registration Number": "TL/MD/2022/000004",
|
|
"Scope Of Testing": "1. X-ray Equipment for Radiography and Radioscopy — Class C\r\n2. Cardiac Defibrillators — Class C\r\n3. Invasive Blood Pressure MonitoringEquipment - Class C \r\n4. Mammographic X-ray Equipment and Mammographic Stereotactic Devices - Class C\r\n5. Peritoneal Dialysis Equipment -Class C\r\n6. Ultrasonic Medical Diagnostic andMonitoring Equipment - Class B \r\n7. X-ray Equipment for Interventional Procedures - Class C"
|
|
},
|
|
{
|
|
"SL_NO": 23,
|
|
"Name and Address of the Testing Laboratory": "M/s INSTITUTE FOR INDUSTRIAL \r\nRESEARCH & TOXICOLOGY\r\nF209,1 PHASE 1, UPSIDC, M.G ROAD,\r\nGhaziabad, Uttar Pradesh, 201001 \r\nGhaziabad (India) -245101",
|
|
"Registration Number": " TL/MD/2022/000005",
|
|
"Scope Of Testing": "1.Foley Catheter Two way (TestParameter BET and Sterility) - Class D\r\n2. DISPOSABLE \tELECTRODERECORDING \tCATHETER \t(Test \r\nParameter-BET and Sterility) - Class D\r\n3. INTRODUCER SHEATHCATHETER (Test Parameter-BET and Sterility) - Class D\r\n4. DOUBLE LUMEN CATHETER SET (Test Parameter-BET and Sterility) -Class D\r\n5. DISPOSABLE CENTRAL VENOUS CATHETER (Test Parameter-BETand Sterility) - Class D\r\n6. DOLPHIN SUTURES (Test parameter Sterility) - Class C\r\n7. DISPOSABLE EMBOLECTOMYCATHETER (Test Parameter-BET and Sterility) - Class D\r\n8. DISPOSABLE THERMODILUTION CATHETER (Test Parameter-BET and Sterility) - Class D\r\n9. Foley Catheter Two way (TestParameter BET and Sterility) -Class B\r\n10. Male Catheter (Test Parameter-BET and Sterility) - Class B\r\n11. Ryles \tTube \t14FG \t(TestParameter-BET, \tBioburdan \tand Sterility) - Class B\r\n12. Endotracheal tube \t(TestParameter-BET, \tBioburdan \tand Sterility) - Class B\r\n13. Coronary Artery Cannula (Test Parameter-BET and Sterility) - Class B\r\n14. Natural rubber latex condom(Test Parameter-BET ) - Class B\r\n15. Urethreal \tCatheter (TestParameter-BET and Sterility) -Class D\r\n16. Multiple Lumen Catheter (Test Parameter-BET and Sterility) -Class B\r\n \r\n "
|
|
},
|
|
{
|
|
"SL_NO": 24,
|
|
"Name and Address of the Testing Laboratory": "M/s Vorick AnalyticalResearch Pvt. Ltd.\r\nPlot No. 252, Sector — K, Bhorgarh Industrial Area, Bawana-II,Narela, North Delhi, Delhi (India) - 110040\r\n ",
|
|
"Registration Number": " TL/MD/2022/000006 ",
|
|
"Scope Of Testing": "1. Lint Bandage - Dimensions, pH Value, Scouring Loss, Freedom from optical Witness Class A\r\n2. Heart Valves - Heavy toxic metalsas \tArsenic, lead, Cadmium,Mercury Particulate Contamination, Sterility Class D\r\n3. Disposable Perfusion \tset \t-Particulate contamination, Tubing length, Flow rate, Heavy Metals, Acidity or alkalinity, Residue on evaporation, UV absorption of extract solution, Sterility Class B \r\n4. Heavy toxic metals as Arsenic,lead, \tCadmium, \tMercury,Particulate Contamination, Mercury Class D\r\n5. Ablation Devices -Heavy toxicmetals as Arsenic, lead, Cadmium,Mercury,Particulate Contamination, Sterility Class C\r\n6. Ablation Devices- Heavy toxicmetals as Arsenic, lead, Cadmium, Mercury, Particulate Contamination, Sterility Class D\r\n7. Cardiac Stents - Heavy toxicmetals \tas Arsenic, lead, Cadmium, Mercury, Particulate Contamination, Sterility Class D\r\n8. Disposable Hypodermic Syringe - Capacity, Fiducial Line, Limits for acidity \tor alkalinity, Metal,Lubricant, Scale, Barrel, Piston,Nozzle, Performance, Reducing substances, Sterility Class B\r\n9.Bone\tCements-Heavy\ttoxicmetals\tas\tArsenic,\tlead,Cadmium, Mercury, Sterility ClassC\r\n10.Contraceptives-Heavy toxicmetals as Arsenic,lead,Cadmium,Mercury,Water Leakage test, Bursting volumeand pressure test, dimension,Sterility Class C\r\n11.Contraceptives-Heavytoxicmetals\tas\tArsenic,\tlead, Cadmium,Mercury,WaterLeakage test, Bursting volume and pressure test, dimension,Sterility Class D\r\n12.Disinfectant-Efficacy Test Class B\r\n13.Disposable Hypodermic Needles -Limits for acidity or alkalinity, Limits for extractable metals, Size designation,\tColour\tcoding,Needle hub, tube, point, Sheath, Performance, Sterility Class B\r\n14. VD Kits - Sterility Class B\r\n15. IVD Kits - Sterility Class C\r\n16.IVD Kits - Sterility Class D\r\n17.Blood Bags- Length, Width,Diameter, Leakage test, Limit of acidity or alkalinity, Heavy toxicmetals as Arsenic,lead, Cadmium, Mercury, Sterility ClassC\r\n18. Disposable Hypodermic Needles -Limits for acidity or alkalinity, Limits for extractable metals, Sizedesignation,Colourcoding,Needle hub, tube, point, Sheath,Performance, Sterility Class C\r\n19.Internal Prosthesis\t- Heavy toxicmetals\tas\tArsenic,lead, Cadmium,Mercury ParticulateContamination, Sterility Class D\r\n20.IV Cannula- Limits for acidity oralkalinity, Intravascular Catheter, Distal end, Hub, Effective length, Outside Diameter, Corrosion Test, Peak tensile force, Freedom fromleakage, Sterility Class C\r\n21.Surgical Dressing-BleachedGauze, Length, Width, Weight ingm/m2,Scouringloss/Foreignmatter,\tAbsorbency,\tFreedom from optical Whitness, pH value of aqueous extract, Sterility Class A\r\n22.Orthopedic Implants- Heavy toxicmetals as Arsenic,\tlead,\r\nCadmium, Mercury,Particulate Contamination, Sterility Class D\r\n23. Surgical Dressing IHS/ As permanufacturer specifications Class D\r\n24.Internal Prosthesis\t- Heavy toxicmetals as Arsenic,lead,Cadmium,Mercury Particulate Contamination, Sterility Class C\r\n25.Disposable\tPerfusio set-Particulate contamination, Tubing length, Flow rate, Heavy Metals. Acidity or alkalinity. Residue on evaporation, UV absorption of extract solution, Sterility Class A\r\n26.Surgical Dressing- Bleached Gauze, Length, Width, Weight in gm/m2,Scouringloss/Foreign matter,Absorbency,\tFreedom from optical Whitness, pH value of aqueous extract, Sterility Class C\r\n27.IV Cannula\t- Limits for acidity oralkalinity, Intravascular Catheter, Distal end, Hub, Effective length, Outside Diameter, Corrosion Test, Peak tensile force, Freedom from leakage, Sterility Class B\r\n28.Crepe Bandages- Dimensions,Weight\tper\tunit\tarea, Stretchability,\tbreaking load,Chemical Neutrality. Class A\r\n29.POP Bandages- Setting Time,Tensile Strength,\tCompressive strength Class A\r\n30.Disposable\tPerfusion set-Particulate contamination, Tubing length, Flow rate, Heavy Metals, Acidity or alkalinity, Residue on evaporation, UV absorption of extract solution, Sterility Class C\r\n31. Catheters-\tLength,\tDiameter,Heavy toxic metals as Arsenic,lead,Cadmium,\tMercury,Particulate Contamination, Sterility Class A\r\n32.Catheters-\tLength,\tDiameter,Heavy toxic\tmetals as Arsenic,lead,\tCadmium,Mercury,Particulate Contamination, Sterility Class B\r\n33.Catheters-Length,Diameter,Heavy toxic metals as Arsenic,lead,Cadmium,Mercury,Particulate Contamination, Sterility Class C\r\n34.Catheters-Length,\tDiameter,Heavy toxic metals as Arsenic,lead,\tCadmium,Mercury,Particulate Contamination, SterilityClass D\r\n35.Orthopedic Implants- Heavy toxicmetals\tas\tArsenic,lead, Cadmium,Mercury,Particulate Contamination, Sterility Class C\r\n36.Surgical Dressing- BleachedGauze, Length, Width, Weight ingm/m2, Scouring loss/Foreign matter,Absorbency,Freedom from optical Whitness, pH value of aqueous extract, Sterility Class B\r\n37.Disposable Hypodermic Syringe-Capacity, Fiducial Line, Limits for acidity\toralkalinity,Metal,Lubricant, Scale, Barrel, Piston,Nozzle, Performance Reducing substances, Sterility Class B\r\n38.Rolled Bandage - Dimensions, pHValue, Scouring Loss,Freedom from optical Witness Class A\r\n"
|
|
},
|
|
{
|
|
"SL_NO": 25,
|
|
"Name and Address of the Testing Laboratory": "M/s, TUV Rheinland(India) Pvt. Ltd.,\t\r\nsituated at Survey No 480/2, AMTZ\t\r\nCampus,NadupuruVillage.Pedagantyada,Pragati Maidan,-Visakhapatnam,\r\nAndhra Pradesh -530031",
|
|
"Registration Number": "TL/MD/2022/000007",
|
|
"Scope Of Testing": "1. Medical\tElectrical\tEquipments-(India) Pvt. Ltd.,\tIEC/EN 60601-1/IS\t13450\t(Part\t1)Class A\r\n2. Electrical Safety Testing\t- Pulse480/2, AMTZ\tOximeter, Oxygen Concentrator,Electrocardiograph Class C\r\n3.Electro Magnetic Interference andPedagantyada,\tElectro\tMagnetic Compatibility,\t(EMI/EMC)-Electro\tMedical Equipment Class C\r\n4.Personal Protectives\t(Coverall,530031 Surgical Masks,\tFiltertype\r\nParticulate Matter Respirator,Medical Textile,Face\tMask,\r\nSurgicalGowns and Surgical Drapes) Class A\r\n5. Personal Protectives(Coverall,Surgical\tMasks,\tFilter\ttype\r\nParticulateMatterRespirator ,MedicalTextile,FaceMask,SurgicalGownsand Surgical Drapes) Class B\r\n6. Bioburden\tTesting\t(DisposableHypodermic\tNeedles,\t SurgicalDressings. Medical Textile) Class A\r\n7. In-Vitro Cytotoxicity Test(Disposable Hypodermic Needles, Surgical Dressings, Medical Textile) Class A\r\n8. Electrical Safety Testing \t- PulseOximeter, Oxygen Concentrator, Electrocardiograph Class B\r\n9. Electro Magnetic Interference and ElectroMagneticCompatibility\r\n(EMI/EMC)\t-Electro MedicalEquipments Class A\r\n10. Electrical Safety Testing - PulseOximeter, Oxygen Concentrator, Electrocardiograph Class A\r\n11. Electro Magnetic Interference and Electro Magnetic\r\nCompatibility(EMI/EMC)-Electro MedicalEquipments Class B\r\n12. Bioburden\tTesting\t(Disposable Hypodermic Needles,Surgical\r\nDressings, Medical Textile) Class B\r\n13. Medical\tElectrical Equipments-IEC/EN 60601-1/IS\t13450\r\n(Part 1)Class B\r\n14. Medical Electrical Equipments-IEC/EN 60601-1/IS13450 (Part\t1)Class C\r\n15. In-Vitro\tCytotoxicity\tTest(Disposable Hypodermic Needles,\r\nSurgical Dressings, Medical Textile)Class B"
|
|
},
|
|
{
|
|
"SL_NO": 26,
|
|
"Name and Address of the Testing Laboratory": "M/s, SHREE BALAJITEST LAB PVT. LTD.\r\nsituated atC-181, NARAINA INDUSTRIAL AREA\r\nPHASE-1 , New Delhi- 110028",
|
|
"Registration Number": "TL/MD/2022/000008 ",
|
|
"Scope Of Testing": "1. Surgical Gloves (Physiochemical,BET and Sterility) Class A\r\n2. Disinfectant Class B\r\n3. Catheters (Physiochemical, BETand Sterility) Class C\r\n4. Cardiac Stents (BET and Sterility) Class D\r\n5. Disposable Hypodermic Needles (Physiochemical, BET and Sterility)Class B\r\n6. Blood Bags (Physiochemical, BET and Sterility) Class C\r\n7. Surgical Dressings(Physiochemical, BET and Sterility) Class B\r\n8. Scalp Vein Sets (Physiochemical, BET and Sterility) Class B\r\n9. Face Mask (BET and Sterility)Class A\r\n10. Orthopedic Implants(Physiochemical, BET and Sterility) Class C\r\n11. Disposable Hypodermic Syringe(Physiochemical, BET and Sterility) Class B\r\n12. Disposable Perfusion Sets(Physiochemical, BET and Sterility) Class B\r\n13. Surgical Sutures (Physiochemical, BET and Sterility) Class C\r\n14. I.V Cannula (Physiochemical, BET and Sterility) Class B"
|
|
},
|
|
{
|
|
"SL_NO": 27,
|
|
"Name and Address of the Testing Laboratory": "M/s, INTERSTELLER TESTING CENTRE PVT. LTD.\r\nSituated at 86,Industrial Area, Phase 1. Panchkula,Haryana - 134109\r\n ",
|
|
"Registration Number": "TL/MD/2022/000009 ",
|
|
"Scope Of Testing": "1. Suprapubic or non disposable cannula (Test parameter- Sterility and BET) Class B\r\n2. Disposable Hypodermic needles(Test parameter- Sterility and BET)Class B\r\n3. Nasogastric Tube/ Ryles Tube (Test parameter- Sterility and BET) Class B\r\n4. Disposable perfusion set (Test parameter Sterility and BET) Class B\r\n5. Feeding Tube (Test parameter- Sterility and BET) Class B\r\n6. Gastrointestinal Tube (Test parameter Sterility and BET) Class B\r\n7. Gastro-Enterostomy Tube (Test parameter- Sterility and BET) Class B\r\n8. Bolster Suture (Test parameter- Sterility and BET) Class A\r\n9. Blood Transfusion \tset (Test parameter Sterility and BET) Class B\r\n10. Urinary Drainage \tUnit (TeiFparameter Sterility and BET) Class B\r\n11. Upper Urinary tract catheter (Test parameter- Sterility and BET) Class B\r\n12. Foley Catheter (Test parameter- Sterility and BET) Class B\r\n13. Coude catheter (Test parameter- Sterility and BET) Class B\r\n14. Alcohol Swabs (Test parameter- Sterility and BET) Class A\r\n15. Surgical Dressing (Test parameterSterility and BET) Class A\r\n16. Nasopharyngeal Catheter(Test parameter- Sterility and BET) Class A\r\n17. Disposable Hypodermic Syringe(Test parameter- Sterility and BET) Class B\r\n18. Contraceptives (Test parameter-Sterility and BET) Class C\r\n19. Intraocular lenses (Test parameterSterility and BET) Class C\r\n20. Surgical stapler (Test parameter-Sterility and BET) Class B\r\n21. Orthopaedic implants(Test parameter Sterility and BET) Class B\r\n22. InternalProsthetic placements (Test parameter- Sterility and BET) Class C\r\n23. Ablation device (Test parameter-Sterility and BET) Class C\r\n24. IV cannula \t(Test parameter- Sterilityand BET) Class B"
|
|
},
|
|
{
|
|
"SL_NO": 28,
|
|
"Name and Address of the Testing Laboratory": "M/s, Yadav Private Limited\t\r\nsituated at Plot No 373-375,Kaladwas, Udaipur ,Rajasthan, India-313003",
|
|
"Registration Number": "TL/MD/2022/000010",
|
|
"Scope Of Testing": "1.Medical Electrical Equipments Measurements (EN/IEC 60601-1-2) Class A \r\n2. In Vitro Diagnostic(IVD) Medical Electrical equipments(IEC\t61326-2-6) Class A\r\n3.In Vitro Diagnostic(IVD) Medical RIICO Bhamashah Electrical equipments (IEC 61326-Industrial Area 2-6) Class C\r\n4. Electro Magnetic Interference and Electro Magnetic Compatibility 313003(EMI/EMC)-Electro Medical and IVD Equipments (Basic Standard) Class A\r\n5. Electro Magnetic Interference and Electra \tMagnetic \tCompatibility (EMI/EMC)-Electro Medical and IVD Equipments (Basic Standard) Class C\r\n6.Medical Electrical Equipments (EN/IEC 60601-1-2) Class C\r\n7.In-Vitro Diagnostic (IVD) MedicalElectrical equipments\t(1EC 61326-2-6) Class B\r\n8.Electra Magnetic Interference and Electro Magnetic Compatibility\r\n(EMI/EMC)-Electro Medical and IVD Equipments (Basic Standard) Class B\r\n9.Medical Electrical Equipments (EN/IEC 60601-1-2) Class B\r\n\r\n",
|
|
}
|
|
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|
|
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{
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data: 'Scope Of Testing',
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render: (data) => {
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const listItems = data.replaceAll('\r\n', '<br/><br/>');
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return listItems;
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}
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}
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]
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});
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|
});
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</script>
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</body>
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</html>
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