VitaVitro Sperm Gradient Medium SG-80, 125 mL
by Shenzhen Vitavitro Bio-Tech Co., Ltd.
VitaVitro Sperm Gradient Medium SG-80, 125 mL (V01512580) is an IVF medium (FDA Class II; FDA product code MQL, Media, Reproductive) made by Shenzhen Vitavitro Bio-Tech Co., Ltd., cleared under FDA 510(k) K212410 on 1 Feb 2022 and listed in FDA GUDID since 11 Feb 2022 (UDI-DI 06971982050168), 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 | Number06971982050168 | Date11 Feb 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212410 | Date1 Feb 2022 | StatusActive |
Official records
- AccessGUDID record 06971982050168
- FDA 510(k) database K212410
Across registries
- FDA 510(k) K212410 decided 1 Feb 2022 Active
- FDA GUDID UDI-DI 06971982050168 listed 11 Feb 2022 Listed
Timeline
- Cleared FDA 510(k) K212410
- Listed FDA GUDID 06971982050168
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VitaVitro
- Generic name
- IVF medium
- Model / Ref / Catalog
- Sperm Gradient Medium SG-80, 125 mL, V01512580
- Primary DI / UDI-DI
- 06971982050168
- 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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