Identity
- Trade Name
- MGIT EUDAMED
- Device Name
- BD MGIT™ TBc Identification Test EUDAMED
- Model / Reference
- 245159 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30382902451595 EUDAMED
- Basic UDI-DI
- 038290WOGVLVPOQK EUDAMED
- Unit of Use DI
- 00382902451594 EUDAMED
- EMDN Code
- W0105010701 MYCOBACTERIAL ANTIGEN DETECTION 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
No
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
Mgit by Becton, Dickinson and Company — 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 | 038290WOGVLVPOQK | Class C | 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 ce03ed76-518e-4753-b449-47034861db93 61 fields · synced Oct 6, 2026