NMPA Approved 107 Medical Devices in June 2020
In June 2020, NMPA has approved a total of 107 medical devices. 59 of them are domestic Class III medical devices, 24 of them are imported Class III medical devices, 24 of them are imported Class II medical devices.
Link: http://www.nmpa.gov.cn/WS04/CL2121/378693.html
Please find the approved imported medical devices in June 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 June 2020
| No. |
Product Name |
Registrant Name |
Certificate Number |
| Imported Class III Medical Devices |
| 1. |
Transcatheter Aortic Value System |
Edwards Lifesciences LLC |
国械注进20203130291 |
| 2. |
InMode RF System |
Invasix Ltd. |
国械注进20203090292 |
| 3. |
Micron continuous wave surgical laser |
LISA Laser Products GmbH |
国械注进20203010293 |
| 4. |
Surpass Streamline Flow Diverter |
Stryker Neurovascular |
国械注进20203130307 |
| 5. |
Accessory for ULTRA Therapies for Hemodialysis |
Gambro Dasco S.p.A Medolla Facility |
国械注进20203100308 |
| 6. |
Arterial and Venous Cannula |
Medtronic Inc. |
国械注进20203100309 |
| 7. |
Tooth Whitening Gel |
Discus Dental, LLC |
国械注进20203170310 |
| 8. |
G-TLTM medium for culture of embryos from fertilization to the blastocyst |
Vitrolife Sweden AB |
国械注进20203180311 |
| 9. |
INFINITY™ OCT System |
Medtronic Sofamor Danek USA, Inc. |
国械注进20203130312 |
| 10. |
Resin Material for Crowns and Bridges |
Coltène/Whaledent AG |
国械注进20203170313 |
| 11. |
ASAHI Corsair Pro Microcatheter |
朝日インテック株式会社 |
国械注进20203030314 |
| 12. |
Tooth Whitening Gel |
Discus Dental, LLC |
国械注进20203170315 |
| 13. |
Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens |
Bausch & Lomb Incorporated |
国械注进20203160316 |
| 14. |
VIDEO LOWER G.I.SCOPE |
HOYA株式会社 |
国械注进20203060317 |
| 15. |
VIDEO UPPER G.I.SCOPE |
HOYA株式会社 |
国械注进20203060318 |
| 16. |
EPD Cardiac Mapping and Navigation System |
EPD Research Ltd. |
国械注进20203070319 |
| 17. |
Medical therapeutic laser device |
OPTOTEK d.o.o. |
国械注进20203160320 |
| 18. |
Diagnostic Support Software |
Hanalytics Pte.Ltd. |
国械注进20203210321 |
| 19. |
Ultrasound System |
Philips Ultrasound, Inc. |
国械注进20203060322 |
| 20. |
Medical Angiography X-ray System |
Philips Medical Systems Nederland B.V. |
国械注进20203060323 |
| 21. |
PET/CT Imaging System |
Siemens Medical Solutions USA, Inc. |
国械注进20203060324 |
| 22. |
MitraClip System |
Abbott Vascular |
国械注进20203130325 |
| 23. |
Mammography System |
Hologic, Inc. |
国械注进20203060333 |
| 24. |
Computed tomography x-ray system |
GE MEDICAL SYSTEMS, LLC |
国械注进20203060334 |
| Imported Class II Medical Devices |
| 25. |
Endovision Camera Systems |
KARL STORZ SE & Co. KG |
国械注进20202060294 |
| 26. |
Processor |
富士フイルム株式会社 |
国械注进20202060295 |
| 27. |
Polysomnographs |
SOMNOmedics GmbH |
国械注进20202070296 |
| 28. |
Cardiac Testing System |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
国械注进20202070297 |
| 29. |
Mobile radiography X-ray equipment |
Siemens Healthcare GmbH |
国械注进20202060298 |
| 30. |
Alinity c Iron Calibrator Kit |
Abbott GmbH & Co. KG |
国械注进20202400299 |
| 31. |
Anti-mullerian hormone assay Kit (enzyme-linked immunofluorescence method) |
BIOMERIEUX S.A. |
国械注进20202400300 |
| 32. |
High Sensitive Troponin I Low Value Control |
Ortho-Clinical Diagnostics |
国械注进20202400301 |
| 33. |
B·R·A·H·M·S PCT Calibrators |
Immunotech SAS, A Beckman Coulter Company |
国械注进20202400302 |
| 34. |
Orthodontic Ceramic Bracket |
GNI Co.,Ltd |
国械注进20202170303 |
| 35. |
Drill for Template Fixation Pin |
Institut Straumann AG |
国械注进20202170304 |
| 36. |
Ezi-Crown Light Cured, Temporary Crown and Bridge Resin |
(주)메디클러스 |
国械注进20202170305 |
| 37. |
Symetri Clear |
Ormco Corporation |
国械注进20202170306 |
| 38. |
TEG® 6s Hemostasis System |
Haemonetics S.A. |
国械注进20202220326 |
| 39. |
UV Phototherapy Device |
澁谷工業株式会社 |
国械注进20202090327 |
| 40. |
Medical Image Processing Software |
Materialise N.V. |
国械注进20202210328 |
| 41. |
Biological Microscope |
株式会社二コン |
国械注进20202220329 |
| 42. |
Automated Biochemical Analyzer |
TOKYO BOEKI MEDISYS INC. |
国械注进20202220330 |
| 43. |
aPTT Screen |
Roche Diagnostics GmbH |
国械注进20202400331 |
| 44. |
D-DI2 |
Roche Diagnostics GmbH |
国械注进20202400332 |
| 45. |
NASAL SOLUTIONS |
GEROLYMATOS INTERNATIONAL S.A. |
国械注进20202140335 |
| 46. |
Myringotomy Kits |
Exmoor Plastics Ltd |
国械注进20202020336 |
| 47. |
Transparent adhesive dressing |
Jiangxi 3L Medical Products Group (cambodia) Co.,Ltd |
国械注进20202140337 |
| 48. |
Inflator |
Genoss Co., Ltd.吉诺斯株式会社 |
国械注进20202030338 |
|
