DiaRapid FOB Rapid Test Cassette
by Hangzhou Alltest Biotech.Co., Ltd.
Ref SFO-602H
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06936983198455 06936983198455 | Date9 Dec 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- SFO-602H
- Primary DI / UDI-DI
- 06936983198455
- Basic UDI-DI
- B-06936983198455
- EMDN Code
- W01029099 Immunochemistry reagents - other
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- France
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 (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No