Identity
- Trade Name
- BACTEC EUDAMED
- Device Name
- BD BACTEC™ FXI Culture System Analyzer Module EUDAMED
- Model / Reference
- 445350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382904453503 EUDAMED
- Basic UDI-DI
- 038290INRHSICXE8 EUDAMED
- EMDN Code
- W02030201 AUTOMATED BLOOD CULTURE ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Bactec by Becton, Dickinson and Company — Class A — CE/MDR — 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 | 038290INRHSICXE8 | Class A | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (1)
- EUDAMED 00851d8f-7341-48ca-89a1-a8429e5a8880 61 fields · synced Oct 7, 2026