Identity
- Trade Name
- BD TRITEST EUDAMED
- Device Name
- BD Tritest™ CD3/CD4/CD45 EUDAMED
- Model / Reference
- 342413 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382903424139 EUDAMED
- Basic UDI-DI
- 038290HDBEZCGMYY EUDAMED
- EMDN Code
- W0103080101 ANTIBODIES FOR B AND T-CELL SUBTYPING EUDAMED
Classification
- Device Class
- Class C 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
Bd Tritest by Becton, Dickinson and Company, BD Biosciences — Class C — 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 | 038290HDBEZCGMYY | Class C | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- EUDAMED SRN
- US-MF-000017797
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (1)
- EUDAMED 40fd6278-7db6-4825-ba0c-3008b04ffa10 61 fields · synced Jul 31, 2026