NMPA Approved 37 Medical Devices on March 12, 2020
On March 12, 2020, NMPA has approved a total of 37 imported medical devices listed in the following table. But all these certificates are renewed, not the initial registration. 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 info@inspirativemed.com.
Link: https://www.cmde.org.cn/CL0151/20584.html
| No. | Product Name | Registrant Name |
| 1. | Operative Hysteroscopy Instruments | XION GmbH |
| 2. | Accessories of Laparoscopy | PAJUNK GmbH Medizintechnologie |
| 3. | HF-electrodes | Pajunk GmbH Medizintechnologie |
| 4. | The TECNIS® Multifocal 1-Piece IOL | Johnson & Johnson Surgical Vision, Inc. |
| 5. | Introducer for PTCA Guiding Catheters | テルモ株式会社 |
| 6. | Silicone Oil | FRANCE CHIRURGIE INSTRUMENTATION SAS(FCI S.A.S.) |
| 7. | Cementless Acetabular Cup System | Waldemar Link GmbH & Co. KG |
| 8. | LINK Cementless Hip Prostheses Stems Standard P | Waldemar Link GmbH & Co. KG |
| 9. | Cementless Acetabular Cup System | Waldemar Link GmbH & Co. KG |
| 10. | Abutments and Accessories | B. & B. Dental s.r.l. |
| 11. | Tonometer | Icare Finland Oy |
| 12. | Tonometer | Icare Finland Oy |
| 13. | Juvéderm ULTRA | Allergan |
| 14. | Juvéderm ULTRA | Allergan |
| 15. | SmartFibers | TRIMEDYNE, INC. |
| 16. | Disposable Sterile Laser Sheath | TRIMEDYNE, INC. |
| 17. | Fluorescence Imaging System | Novadaq Technologies ULC |
| 18. | SURGICEL Absorbable Haemostat | Ethicon LLc |
| 19. | Holmium Laser | Dornier MedTech GmbH |
| 20. | CytoTherm Plasma Thawing System | CytoTherm LP |
| 21. | CytoTherm Plasma Thawing System | CytoTherm LP |
| 22. | Nerve Stimulator for Plexus Anaesthesia | Stockert GmbH |
| 23. | Lens Insertion Devices | Bausch＆Lomb, Incorporated |
| 24. | Cornea/Anterior Segment OCT | 株式会社トプコン |
| 25. | FibroScan | ECHOSENS |
| 26. | Full Auto Ref-Keratometer | 株式会社ニデック |
| 27. | Camera Systems for Endoscopy | STEMA Medizintechnik GmbH |
| 28. | Cervical Cancer Screening System | TruScreen Limited |
| 29. | Semi-automatic External Defibrillator | ZOLL Medical Corporation |
| 30. | Hematocrit and Metabolite QUALICHECK LEVEL1,2 | Radiometer Medical ApS |
| 31. | Linearity Control for Blood Glucose Detection | Roche Diabetes Care GmbH |
| 32. | Liquid Specific Protein Calibrators | Siemens Healthcare Diagnostics Inc. |
| 33. | Rap/Tac/CsA Control | More Diagnostics Inc. |
| 34. | Accu-Chek Performa control | Roche Diabetes Care GmbH |
| 35. | SERO Maternal Health Control – Early | Wallac Oy |
| 36. | Complement C4 Reagent | Beckman Coulter, Inc. |
| 37. | Total Cholesterol Test Kit (Enzyme Method) | Hitachi Chemical Diagnostics Systems Co., Ltd. |
