Identity
- Trade Name
- TRUPCR® STD Panel Kit EUDAMED
- Device Name
- TRUPCR® STD Panel Kit EUDAMED
- Model / Reference
- 3B292 EUDAMED3B291/C EUDAMED3B291 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908015304934 EUDAMED08908015304132 EUDAMED08908015304927 EUDAMED
- Basic UDI-DI
- 89080153043B291NQ EUDAMED
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX 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® STD Panel 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 | 89080153043B291NQ | 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 (3)
- EUDAMED 528a04f2-037f-46fd-b522-a4a312e86e2b 61 fields · synced Jul 10, 2026
- EUDAMED b250183a-ca65-431b-bf10-0b78f28291f0 61 fields · synced May 18, 2026
- EUDAMED b9d71238-71cf-4a4b-9ae1-d5596ed28011 61 fields · synced May 19, 2026