FOB test
by Salofa Oy Finland EUDAMED
Ref 20-20-xxTEST
EMDN W0102160203
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-FIMF168232020xxTESTPY | Date26 Aug 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- FOB test
- Model / Reference
- 20-20-xxTEST
- Primary DI / UDI-DI
- D-FIMF168232020xxTESTPY
- Basic UDI-DI
- B-FIMF168232020xxTESTPY
- EMDN Code
- W0102160203 Fecal occult blood - rt & poc
- Device Class
- Class IVD General
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- FI-MF-000016823
Other devices from Salofa Oy
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED ac8f1d6f-cb45-4fe5-9ee6-2e01ace4826a