SpermFreeze SPF
by Fertipro NV
SpermFreeze SPF is an IVF medium (FDA Class II; FDA product code MQL, Media, Reproductive) made by Fertipro NV, cleared under FDA 510(k) K053494 on 23 Mar 2006 and listed in FDA GUDID since 19 May 2016 (UDI-DI 05411967002009), 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 | Number05411967002009 | Date19 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK053494 | Date23 Mar 2006 | StatusActive |
Official records
- AccessGUDID record 05411967002009
- FDA 510(k) database K053494
Across registries
- FDA 510(k) K053494 decided 23 Mar 2006 Active
- FDA GUDID UDI-DI 05411967002009 listed 19 May 2016 Listed
Timeline
- Cleared FDA 510(k) K053494
- Listed FDA GUDID 05411967002009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SpermFreeze
- Generic name
- IVF medium
- Model / reference
- SPF
- Primary DI / UDI-DI
- 05411967002009
- 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
- Size
- Total Volume — 20 Milliliter
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