Identity
- Trade Name
- Rhino&EV/Cc R-GENE® EUDAMED
- Device Name
- Rhino&EV/Cc R-GENE® EUDAMED
- Model / Reference
- 71-042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03573026387990 EUDAMED
- Basic UDI-DI
- 357302BUDI000034ST EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France 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
New Device
No
EUDAMED
Rhino&EV/Cc R-GENE® by Biomerieux Sa — 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 | 357302BUDI000034ST | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- bioMérieux SA
- EUDAMED SRN
- FR-MF-000004436
Sources (1)
- EUDAMED 7e27f2d8-030a-4682-ac68-662b4ec550ea 61 fields · synced Jul 11, 2026