Identity
- Trade Name
- TRUPCR® MTBC OneStep Nested Kit EUDAMED
- Device Name
- TRUPCR® MTBC OneStep Nested Kit EUDAMED
- Model / Reference
- 3B268 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908015304170 EUDAMED
- Basic UDI-DI
- 89080153043B268NV EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
TRUPCR® MTBC OneStep Nested Kit by 3B BlackBio Dx Limited — 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 | 89080153043B268NV | Class C | Active |
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Manufacturer
- Manufacturer
- 3B BlackBio Dx Limited
- EUDAMED SRN
- IN-MF-000023698
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED ebe03c2b-02e7-4b93-85d1-d63ef3e09893 61 fields · synced Jul 11, 2026