Identity
- Trade Name
- Phoenix EUDAMED
- Device Name
- BD Phoenix™ NMIC-476 EUDAMED
- Model / Reference
- 449510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30382904495108 EUDAMED
- Basic UDI-DI
- 038290FRPPXVDBJC EUDAMED
- Unit of Use DI
- 00382904495107 EUDAMED
- EMDN Code
- W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Belgium 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
Phoenix by Becton, Dickinson and Company — 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 | 038290FRPPXVDBJC | Class B | 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 541c764d-f509-4908-82bb-78a4e73bfa3b 61 fields · synced Oct 6, 2026