Dewin 9311
by DonneVie Medical Technology(Shanghai)Co.Ltd
Dewin 9311 is a Class II device made by DonneVie Medical Technology(Shanghai)Co.Ltd, cleared under FDA 510(k) K212426 on 16 Jun 2022 and listed in FDA GUDID since 8 Jul 2022 (UDI-DI 06972962312160), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06972962312160 | Date8 Jul 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212426 | Date16 Jun 2022 | StatusActive |
Official records
- AccessGUDID record 06972962312160
- FDA 510(k) database K212426
Across registries
- FDA 510(k) K212426 decided 16 Jun 2022 Active
- FDA GUDID UDI-DI 06972962312160 listed 8 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K212426
- Listed FDA GUDID 06972962312160
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dewin
- Generic name
- IVF medium
- Model / reference
- 9311
- Primary DI / UDI-DI
- 06972962312160
- 510(k) Number
- FDA product code
- MQL
- GMDN term
- IVF medium
- Device class
- Class II
- Regulation number
- 884.6180
- GUDID distribution status
- In Commercial Distribution
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