Identity
- Trade Name
- EurobioPlex BK virus / JC virus EUDAMED
- Device Name
- EurobioPlex BK virus / JC virus EUDAMED
- Model / Reference
- EBX-028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EBX-028QN EUDAMED
- Basic UDI-DI
- B-EBX-028QN EUDAMED
- EMDN Code
- W0105070502 OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
EurobioPlex BK virus / JC virus by Eurobio Scientific — 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-EBX-028QN | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Eurobio Scientific
- EUDAMED SRN
- FR-MF-000011745
Sources (1)
- EUDAMED cee60675-d01a-43ea-b85a-0611ca233ce3 61 fields · synced Jul 28, 2026