Identity
- Trade Name
- HEV IgG (Liquid) Control EUDAMED
- Device Name
- HEV IgG (Liquid) Control EUDAMED
- Model / Reference
- HEV IgG CON EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HEVIgGCONZU EUDAMED
- Basic UDI-DI
- B-HEVIgGCONZU 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
HEV IgG (Liquid) 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-HEVIgGCONZU | 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 5d5164b4-10c9-47d6-95e1-385ffb146666 61 fields · synced Oct 7, 2026