One-Step Immunological Fecal Occult Blood Test
by W.H.P.M. Bioresearch & Technology Co., Ltd. China EUDAMED
Ref WH-FOB-S0x0101; WH-FOB-S0x0102Model Strip; Cassette
EMDN W0103010601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-6909620WHSFOB8VJY | Date10 Mar 2023 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Occult Blood Tests
- Model / Reference
- Strip, Cassette, WH-FOB-S0x0101, WH-FOB-S0x0102
- Primary DI / UDI-DI
- D-6909620WHSFOB8VJY
- Basic UDI-DI
- B-6909620WHSFOB8VJY
- EMDN Code
- W0103010601 Haemoglobin (hb)
- Device Class
- Class IVD devices for self-testing
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000003007
- Authorised representative
- MDSS GmbH DE-AR-000005430
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Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 05e60e18-60ca-40c0-9abc-24851952f865