Qingli
by Zhejiang QL Biotech Co., Ltd. EUDAMED
Active
Ref TFO-602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-26976081910027 | Date26 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Human Fecal Occult Blood (FOB) Rapid Test (Feces)
- Model / Reference
- TFO-602
- Primary DI / UDI-DI
- 26976081910027
- Basic UDI-DI
- B-26976081910027
- EMDN Code
- W0102160203 Fecal occult blood - rt & poc
- Device Class
- Class IVD General
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000034990
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Zhejiang QL Biotech Co., Ltd.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No