ReLIA
by ReLIA Biotechnologies (Jiangsu), Inc. China EUDAMED
Ref RF16041-20T
EMDN W0102069013
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06971354100194 | Date22 May 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Capillary Blood Procalcitonin Test (Fluorescence Immunoassay)
- Model / Reference
- RF16041-20T
- Primary DI / UDI-DI
- 06971354100194
- Basic UDI-DI
- B-06971354100194
- EMDN Code
- W0102069013 Procalcitonin
- Device Class
- Class IVD General
- Market of Registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- CN-MF-000042042
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
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Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 9fae78ba-6c6a-4a32-9c80-c9c06bf37315