Identity
- Trade Name
- INNODX HEV IgM CMIA EUDAMED
- Device Name
- INNODX HEV IgM CMIA EUDAMED
- Model / Reference
- KR-HEV-02100C EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-KR-HEV-02100CZG EUDAMED
- Basic UDI-DI
- B-KR-HEV-02100CZG EUDAMED
- EMDN Code
- W0105020505 HEV ANTIBODY IGM EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
INNODX HEV IgM CMIA 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-KR-HEV-02100CZG | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Innodx Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000041071
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED c83646a7-3650-4842-aa18-d8488e0d819c 61 fields · synced Oct 7, 2026