NMPA Approved 96 Medical Devices in August 2020
In August 2020, NMPA has approved a total of 96 medical devices. 57 of them are domestic Class III medical devices, 13 of them are imported Class III medical devices, 24 of them are imported Class II medical devices and 2 of them is a Taiwan medical device.
Link: https://www.nmpa.gov.cn/xxgk/ggtg/ylqxpzhzhcchpgg/20200916150323159.html
Please find the approved imported medical devices in August 2020 as below. If you want to know
more about your device category, clinical pathways, predicate information and other related to
your China business, please do not hesitate to contact us at info@chinameddevice.cn.
Approved Imported Medical Devices in August 2020
| No. |
Product Name |
Registrant Name |
Certificate Number |
| Imported Class III Medical Devices |
| 1. |
cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 6800/8800 Systems |
Roche Diagnostics GmbH |
国械注进20203400367 |
| 2. |
Cemented EasyHip System |
GO German Orthopedic Implants GmbH |
国械注进20203130386 |
| 3. |
G7 OsseoTi Acetabular Shell |
Biomet Orthopedics |
国械注进20203130387 |
| 4. |
INTRAFIX Advance Tibial Fastener System |
Medos International SARL |
国械注进20203130388 |
| 5. |
Internal Hex (IH) system |
Alpha-Bio Tec LTD. |
国械注进20203170389 |
| 6. |
Combo Bio-Engineered Sirolimus Eluting Stent |
OrbusNeich Medical, B.V. |
国械注进20203130390 |
| 7. |
Continuous Glucose Monitoring (CGM) System |
Medtronic MiniMed |
国械注进20203070391 |
| 8. |
Endoscopes |
Carl Zeiss Meditec AG |
国械注进20203060392 |
| 9. |
VNS Therapy Generator and Accessories System |
LivaNova USA，Inc. |
国械注进20203120393 |
| 10. |
MRI guided radiotherapy system |
Elekta Limited |
国械注进20203050394 |
| 11. |
Bausch + Lomb BiotrueOneday For Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens |
Bausch & Lomb Incorporated |
国械注进20203160401 |
| 12. |
Journey Patello-femoral joint implant |
Smith & Nephew, Inc. |
国械注进20203130402 |
| 13. |
Pen Needle B. Braun F-Pen |
B. Braun Melsungen AG |
国械注进20203140403 |
| Imported Class II Medical Devices |
| 14. |
DR FLFS Detector Positioner |
Agfa NV |
国械注进20202060368 |
| 15. |
ThinPrep Integrated Imager |
Hologic, Inc. |
国械注进20202220369 |
| 16. |
Corvocet Biopsy System |
Merit Medical Systems, Inc. |
国械注进20202140370 |
| 17. |
Single Use Aspiration Needle |
オリンパスメディカルシステムズ株式会社 |
国械注进20202020371 |
| 18. |
Endoscopic visualization systems |
Carl Zeiss Meditec AG |
国械注进20202060372 |
| 19. |
OAE Instrument |
Diagnostic Group LLC Doing Business as Grason-Stadler |
国械注进20202070373 |
| 20. |
Audiometer |
Diagnostic Group LLC, DBA Grason-Stadler |
国械注进20202070374 |
| 21. |
Whitening LED Accelerator |
Discus Dental, LLC |
国械注进20202170375 |
| 22. |
Oximeter/Carbon dioxide gas analyzer |
Nonin Medical, Inc. |
国械注进20202070376 |
| 23. |
PROPHYflex 4 |
Kaltenbach & Voigt GmbH |
国械注进20202170377 |
| 24. |
Neutral Electrodes |
ConMed Corporation |
国械注进20202170378 |
| 25. |
Cal Plasma |
Roche Diagnostics GmbH |
国械注进20202400379 |
| 26. |
SeraSpot® Vaskulitis-3 IgG |
Seramun Diagnostica GmbH |
国械注进20202400380 |
| 27. |
D-DI2 Cal Set |
Roche Diagnostics GmbH |
国械注进20202400381 |
| 28. |
PT Cal Set |
Roche Diagnostics GmbH |
国械注进20202400382 |
| 29. |
Global Cal |
Roche Diagnostics GmbH |
国械注进20202400383 |
| 30. |
IDS-iSYS 25 VitDS Control Set |
Immunodiagnostic Systems Limited |
国械注进20202400384 |
| 31. |
Alinity c UIBC Calibrator Kit |
SENTINEL CH. S.p.A. |
国械注进20202400385 |
| 32. |
VITROS Immunodiagnostic Products Troponin I ES Calibrators |
SYSMEX CORPORATION |
国械注进20202400395 |
| 33. |
VITROS Immunodiagnostic Products NT-proBNP II Calibrators |
Ortho-Clinical Diagnostics |
国械注进20202400396 |
| 34. |
VITROS Chemistry Products Calibrator Kit 32 |
Ortho-Clinical Diagnostics |
国械注进20202400397 |
| 35. |
Steam Autoclave |
EURONDA SPA |
国械注进20202110398 |
| 36. |
Constant temperature incubator |
ASTEC CO.,LTD. |
国械注进20202220399 |
| 37. |
BD PhoenixTM Automated Microbiology System |
Beckman Coulter, Inc. |
国械注进20202220400 |
| Hong Kong, Macao or Taiwan Medical Device |
| 38. |
Ophthalmic camera lens |
Medimaging Integrated Solution Inc. |
国械注许20202160012 |
| 39. |
“HC-Bios” Dental Implant System |
Hung Chun Bio-S CO ,.LTD LuKe Facility |
国械注许20203170013 |
|
