Identity
- Trade Name
- PREVI™ Fluo TB EUDAMED
- Device Name
- PREVI™ Fluo TB EUDAMED
- Model / Reference
- 411010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03573026361174 EUDAMED
- Basic UDI-DI
- 357302BUDI000295TR EUDAMED
- EMDN Code
- W0104010804 STAINS EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
PREVI™ Fluo TB by Biomerieux Sa — Class A — 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 | 357302BUDI000295TR | Class A | 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 847aa54a-177c-48db-bb0f-69c1e74209ef 61 fields · synced Jun 19, 2026