EmbryoGen 12040003D
by Origio A/S
EmbryoGen 12040003D is an IVF medium (FDA Class II; FDA product code MQL, Media, Reproductive) made by Origio A/S, cleared under FDA 510(k) K140317 on 16 Jun 2014 and listed in FDA GUDID since 15 Jul 2016 (UDI-DI 00888937801453), 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 | Number00888937801453 | Date15 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140317 | Date16 Jun 2014 | StatusActive |
Official records
- AccessGUDID record 00888937801453
- FDA 510(k) database K140317
Across registries
- FDA 510(k) K140317 decided 16 Jun 2014 Active
- FDA GUDID UDI-DI 00888937801453 listed 15 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K140317
- Listed FDA GUDID 00888937801453
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EmbryoGen
- Generic name
- IVF medium
- Model / reference
- 12040003D
- Primary DI / UDI-DI
- 00888937801453
- 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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