V-Hyadase
V-Hyadase is an IVF medium (FDA Class II; FDA product code MQL, Media, Reproductive) made by VITROMED GmbH, cleared under FDA 510(k) K222606 on 26 May 2023 and listed in FDA GUDID since 14 Jul 2023 (UDI-DI 04260650070136), active as of 23 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 | Number04260650070136 | Date14 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222606 | Date26 May 2023 | StatusActive |
Official records
- AccessGUDID record 04260650070136
- FDA 510(k) database K222606
Across registries
- FDA 510(k) K222606 decided 26 May 2023 Active
- FDA GUDID UDI-DI 04260650070136 listed 14 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K222606
- Listed FDA GUDID 04260650070136
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- IVF medium
- Model / reference
- V-HYA
- Primary DI / UDI-DI
- 04260650070136
- 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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