Identity
- Trade Name
- VITEK® 2 AST-N445 EUDAMED
- Device Name
- VITEK® 2 AST-N445 EUDAMED
- Model / Reference
- 543380 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03573026634292 EUDAMED
- Basic UDI-DI
- 357302BUDI002035TB EUDAMED
- EMDN Code
- W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED 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
Category: General-microorganism antimicrobial susceptibility culture medium IVD
Vitek® 2 Ast-N445 by Biomérieux — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 357302BUDI002035TB | Class B | Active |
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Manufacturer
- Manufacturer
- bioMérieux, Inc.
- EUDAMED SRN
- US-MF-000011802
- Authorised Representative
- bioMérieux SA FR-AR-000004435
Sources (1)
- EUDAMED 84003c53-2979-431f-abf2-5caa4ac63bf6 61 fields · synced Jul 9, 2026