INNO-LiPA CFTR17 + Tn Strips <20T, CE>
by Fujirebio Europe N.V. EUDAMED
Active
Ref 80581Model 80577
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number54144700014U | Date16 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- INNO-LiPA CFTRiage Strips
- Model / Reference
- 80577, 80581
- Primary DI / UDI-DI
- 05414470805815
- Basic UDI-DI
- 54144700014U
- EMDN Code
- W0106010101 Cystic fibrosis
- Device Class
- Class C
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000001792
Other devices from Fujirebio Europe N.V.
Properties
Show properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No