Unimom Opera+
by Unimom.Co
Unimom Opera+ is a Class II device made by Unimom.Co, cleared under FDA 510(k) K190810 on 30 Aug 2019 and listed in FDA GUDID since 5 Nov 2021 (UDI-DI 08809224872460), 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 | Number08809224872460 | Date5 Nov 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190810 | Date30 Aug 2019 | StatusActive |
Official records
- AccessGUDID record 08809224872460
- FDA 510(k) database K190810
Across registries
- FDA 510(k) K190810 decided 30 Aug 2019 Active
- FDA GUDID UDI-DI 08809224872460 listed 5 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K190810
- Listed FDA GUDID 08809224872460
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Unimom
- Generic name
- Breast pump, electric
- Model / reference
- Opera+
- Primary DI / UDI-DI
- 08809224872460
- 510(k) Number
- FDA product code
- HGX
- GMDN term
- Breast pump, electric
- Device class
- Class II
- Regulation number
- 884.5160
- GUDID distribution status
- In Commercial Distribution
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