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TRUPCR® Tropical Fever Panel Kit
EUDAMEDClass C (EU MDR)
Ref 3B250/CRef 3B299Ref 3B250
Identity
- Trade Name
- TRUPCR® Tropical Fever Panel Kit EUDAMED
- Device Name
- TRUPCR® Tropical Fever Panel Kit EUDAMED
- Model / Reference
- 3B250/C EUDAMED3B299 EUDAMED3B250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906213930016 EUDAMED08908015304293 EUDAMED08908015304286 EUDAMED
- Basic UDI-DI
- 89080153043B250NA EUDAMED
- EMDN Code
- W0105070506 TROPICAL FEVER - 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® Tropical Fever 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 | 89080153043B250NA | 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 4beb11d3-87d9-487b-a0c1-e343e32ef86e 61 fields · synced Jul 16, 2026
- EUDAMED 9e0eb634-fd94-4b53-a6eb-152114d282b1 61 fields · synced May 17, 2026
- EUDAMED 1a38dd87-6a8c-45ff-9b4d-7a730dd7feee 61 fields · synced May 19, 2026