Identity
- Trade Name
- Phoenix EUDAMED
- Device Name
- BD Phoenix™ NMIC/ID-418 EUDAMED
- Model / Reference
- 449012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30382904490127 EUDAMED
- Basic UDI-DI
- 038290GLSOQGQDE4 EUDAMED
- Unit of Use DI
- 00382904490126 EUDAMED
- EMDN Code
- W0104080109 COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM NEGATIVES - AUTOMATED EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 | 038290GLSOQGQDE4 | 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 146f11a6-d21d-4142-a3fd-7b0d555922dd 61 fields · synced Oct 10, 2026