← Back to catalogue
HEPATITIS E VIRCLIA® IgG AVIDITY MONOTEST
EUDAMEDClass B (EU MDR)
Ref VCM093
by Vircell, S.L
Identity
- Trade Name
- HEPATITIS E VIRCLIA® IgG AVIDITY MONOTEST EUDAMED
- Model / Reference
- VCM093 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436040327838 EUDAMED
- Basic UDI-DI
- 843604032VCM09301DK EUDAMED
- EMDN Code
- W0105020504 HEV ANTIBODY IGG EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain 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
New Device
No
EUDAMED
HEPATITIS E VIRCLIA® IgG AVIDITY MONOTEST by Vircell, S.L — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 843604032VCM09301DK | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vircell, S.L
- EUDAMED SRN
- ES-MF-000004099
Sources (1)
- EUDAMED f1013dc8-db1b-4ad8-841c-8628913eab60 61 fields · synced Jun 18, 2026