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Liver Fibrosis (Lyophilized) Control
EUDAMEDClass IVD General (EU MDR)
Ref Liver Fibrosis CON
Identity
- Trade Name
- Liver Fibrosis (Lyophilized) Control EUDAMED
- Device Name
- Liver Fibrosis (Lyophilized) Control EUDAMED
- Model / Reference
- Liver Fibrosis CON EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-LiverFibrosisCONHA EUDAMED
- Basic UDI-DI
- B-LiverFibrosisCONHA EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Liver Fibrosis (Lyophilized) Control by Xiamen Innodx Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-LiverFibrosisCONHA | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Innodx Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000041071
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED fb2972cf-4c1a-4eff-8d90-5eb0ee30872f 61 fields · synced Jun 11, 2026