UNION Immune Analyzer UNION-C
by Shenzhen YHLO Biotech Co., Ltd.
UNION Immune Analyzer UNION-C (U6103) is a Class I device made by Shenzhen YHLO Biotech Co., Ltd., registered in EUDAMED and listed in FDA GUDID since 26 Oct 2022 (UDI-DI 06925912711117), active as of 22 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06925912711117 | Date26 Oct 2022 | StatusListed |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Official records
- EUDAMED public site
- AccessGUDID record 06925912711117
Across registries
- EUDAMED Active
- FDA GUDID UDI-DI 06925912711117 listed 26 Oct 2022 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- UNION Immune Analyzer
- Generic name
- Enzyme immunoassay (EIA) analyser IVD
- Model / Ref / Catalog
- UNION-C, U6103
- Primary DI / UDI-DI
- 06925912711117
- FDA product code
- JJE
- GMDN term
- Enzyme immunoassay (EIA) analyser IVD
- Device class
- Class I
- Regulation number
- 862.2160
- GUDID distribution status
- In Commercial Distribution
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