iFlash-CA242
by Shenzhen Yhlo Biotech Co., Ltd. United States EUDAMED
Ref C86069-S
EMDN W0102030108
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number692591270161HA | Date15 May 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- C86069-S
- Primary DI / UDI-DI
- 06925912721154
- Basic UDI-DI
- 692591270161HA
- EMDN Code
- W0102030108 Cancer antigen 242
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000001137
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Yhlo Biotech Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED babe21b0-75ea-4fe8-a65d-bcdc8d72a44e