NMPA Approved 86 Medical Devices in September 2020
In September 2020, NMPA has approved a total of 86 medical devices. 53 of them are domestic Class III medical devices, 16 of them are imported Class III medical devices, 17 of them are imported Class II medical devices.
Link: https://www.nmpa.gov.cn/xxgk/ggtg/ylqxpzhzhcchpgg/20201023172823129.html
Please find the approved imported medical devices in September 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@inspirativemed.com.
Approved Imported Medical Devices in August 2020
| No. |
Product Name |
Registrant Name |
Certificate Number |
| Imported Class III Medical Devices |
| 1. |
PreciControl HCC |
Roche Diagnostics GmbH |
国械注进20203400407 |
| 2. |
SCC Controls |
Abbott GmbH & Co.KG |
国械注进20203400408 |
| 3. |
ReactTM 71 Catheter |
Micro Therapeutics, Inc. dba ev3 Neurovascular |
国械注进20203030412 |
| 4. |
Single-use electric tube stapler |
ETHICON ENDO-SURGERY, LLC |
国械注进20203010417 |
| 5. |
Continuous Blood purification Equipment |
Nikkiso Europe GmbH |
国械注进20203100418 |
| 6. |
Otolaryngological surgery navigation system |
ClaroNav Kolahi Inc. |
国械注进20203010419 |
| 7. |
VNS Therapy Lead and Accessories |
LivaNova USA, Inc. |
国械注进20203120420 |
| 8. |
Hemodialysis Machine |
日機装株式会社 |
国械注进20203100421 |
| 9. |
Diagnostic U1trasound System and Transducers |
Philips Ultrasound, Inc. |
国械注进20203060422 |
| 10. |
Symbotex™ Composite Mesh |
Sofradim Production |
国械注进20203130424 |
| 11. |
PTCA Catheter |
Blue Medical Devices B.V. |
国械注进20203030425 |
| 12. |
ACCOAT Guide Wires |
SP Medical A/S |
国械注进20203030426 |
| 13. |
Dental root canal filling materials |
META BIOMED CO.,LTD |
国械注进20203170431 |
| 14. |
ACUVUE® OASYS Brand Contact Lenses with HydraLuxe™ for ASTIGMATISM |
Johnson & Johnson Vision Care Inc. |
国械注进20203160432 |
| 15. |
VIA Microcatheter |
Sequent Medical, Inc. |
国械注进20203030433 |
| 16. |
Polaris Spinal System |
Zimmer Biomet Spine, Inc. |
国械注进20203130434 |
| Imported Class II Medical Devices |
| 17. |
Optilene Nonabsorbable Surgical Suture |
B.Braun Surgical S.A. |
国械注进20202020404 |
| 18. |
BARD® MARQUEE® Disposable Core Biopsy Instrument |
Bard Peripheral Vascular, Inc. |
国械注进20202140405 |
| 19. |
Single-use Trocar System Uno Colorline,sterile |
Geuder AG |
国械注进20202160406 |
| 20. |
Audio Processor |
MED-EL Elektromedizinische Geräte GmbH |
国械注进20202120409 |
| 21. |
Dental handpiece |
MicroNX Co., Ltd. |
国械注进20202170410 |
| 22. |
Micro Drill and Shaver System SpeedSurg |
Spiggle ＆ Theis Medizintechnik GmbH |
国械注进20202010411 |
| 23. |
Disposable high frequency surgical electrodes |
Megadyne Medical Products Inc. |
国械注进20202010413 |
| 24. |
Dental Drill System |
Bien-Air Dental SA |
国械注进20202170414 |
| 25. |
HISCL |
シスメックス株式会社 |
国械注进20202400415 |
| 26. |
UIBC |
SENTINEL CH. S.p.A |
国械注进20202400416 |
| 27. |
LMA® GastroTM Cuff PilotTM |
Teleflex Medical |
国械注进20202080423 |
| 28. |
Medical Image Processsing Software |
GE Medical Systems, LLC |
国械注进20202210427 |
| 29. |
Diagnostic X-ray System |
Philips Medical Systems DMC GmbH |
国械注进20202060428 |
| 30. |
BARD® MARQUEE® Disposable Core Biopsy Instrument Kit |
Bard Peripheral Vascular, Inc. |
国械注进20202140429 |
| 31. |
EEA Circular Stapler with Tri-Staple |
Covidien llc |
国械注进20202020430 |
| 32. |
Oral Care Gel |
Discus Dental LLC |
国械注进20202170435 |
| 33. |
EEA Circular Stapler with Tri-Staple Technology |
Covidien llc |
国械注进20202020436 |
|
