Identity
- Trade Name
- COVID-19 R-GENE® EUDAMED
- Device Name
- COVID-19 R-GENE® EUDAMED
- Model / Reference
- 424017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03573026624576 EUDAMED
- Basic UDI-DI
- 357302BUDI000911TU EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - 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
Yes
EUDAMED
Covid-19 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 | 357302BUDI000911TU | Class B | Active |
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Manufacturer
- Manufacturer
- bioMérieux SA
- EUDAMED SRN
- FR-MF-000004436
Sources (1)
- EUDAMED bef69b4e-6f75-4713-abe9-b93b964313c0 61 fields · synced Aug 4, 2026