Identity
- Trade Name
- Novodiag Bacterial GE+ EUDAMED
- Device Name
- Novodiag Bacterial GE+ EUDAMED
- Model / Reference
- NVD-BGE-012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430041761761 EUDAMED
- Basic UDI-DI
- B-06430041761761 EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Novodiag Bacterial GE+ by Mobidiag Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06430041761761 | Class IVD General | No Longer Active |
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Manufacturer
- Manufacturer
- Mobidiag Ltd.
- EUDAMED SRN
- FI-MF-000001215
Sources (1)
- EUDAMED 0aab1735-e58e-42b8-b35e-c8216ee0ceb8 61 fields · synced Jul 24, 2026