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INFLUENZA A ELISA IgG/IgM
EUDAMEDClass IVD General (EU MDR)
Ref G/M1007
by Vircell, S.L
Identity
- Trade Name
- INFLUENZA A ELISA IgG/IgM EUDAMED
- Device Name
- INFLUENZA A ELISA IgG/IgM EUDAMED
- Model / Reference
- G/M1007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436040320259 EUDAMED
- Basic UDI-DI
- B-08436040320259 EUDAMED
- EMDN Code
- W0105040604 INFLUENZA & PARA INFLUENZA EUDAMED
Classification
- Device Class
- Class IVD General 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
INFLUENZA A ELISA IgG/IgM by Vircell, S.L — 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-08436040320259 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vircell, S.L
- EUDAMED SRN
- ES-MF-000004099
Sources (1)
- EUDAMED f67d9a04-3ae2-4dd4-b2ce-e645c8191266 61 fields · synced Jul 8, 2026