Fecal Occult Blood Test
by Shanghai Chemtron Biotech Co., Ltd. China EUDAMED
Ref 9001C 9001SModel Strip, Cassette EMDN W0102160199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-CNM0000180729001NM | Date25 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Fecal Occult Blood Test
- Model / Reference
- Strip, Cassette, 9001C 9001S
- Primary DI / UDI-DI
- D-CNM0000180729001NM
- Basic UDI-DI
- B-CNM0000180729001NM
- EMDN Code
- W0102160199 Specific proteins rt & poc - other
- Device Class
- Class IVD devices for self-testing
- Market of Registration
- Greece
Manufacturer details
- EUDAMED SRN
- CN-MF-000018072
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shanghai Chemtron Biotech Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 28a46740-760c-4eec-ac18-1d721ccef09a