Bowel Health (FOB) Rapid Test
by Hangzhou Alltest Biotech.Co., Ltd. 37 variants
Ref TFO-N602HB-01
Active
CE IVDR
Valid until
11 Aug 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberV76 095123 0020 | Date23 Jun 2026 | StatusActive |
Certificates
- V76 095123 0020 Active
Technical documentation EU IVDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 23 Jun 2026
- Expires
- 11 Aug 2030
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- One+Step Bowel Health (FOB) Rapid Test
- Model / Reference
- TFO-N602HB-01
- Primary DI / UDI-DI
- 06936983199124, 06936983178815, 06936983199100, 06936983199131, 06936983199117, 06936983199087, 06936983199094
- Basic UDI-DI
- 6970277510014RYW
- EMDN Code
- W0101060399 Faeces tests - rapid tests and "point of care" - other
- Device Class
- Class C
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000010710
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Hangzhou Alltest Biotech.Co., Ltd.
Properties
Other properties (8)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No