Identity
- Trade Name
- COR EUDAMED
- Device Name
- BD Enteric Bacterial Panel Diluent for BD COR™ EUDAMED
- Model / Reference
- 445279 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30382904452798 EUDAMED
- Basic UDI-DI
- 038290FIJFRVAY7J EUDAMED
- Unit of Use DI
- 00382904452797 EUDAMED
- 510(k) Number
- K250358 FDA 510(k)
- FDA Product Code
- PCI FDA 510(k)
- EMDN Code
- W0105050201,W0105050207,W0105050208 EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3990 FDA 510(k)
- Regulation Number
- 866.3990 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Cor by Becton, Dickinson and Company — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250358 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 038290FIJFRVAY7J | 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 (2)
- EUDAMED 182d73d8-a089-4904-a13b-c11e75bb9ba5 61 fields · synced Oct 7, 2026
- FDA 510(k) K250358 24 fields · synced May 18, 2026