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TRUPCR® TORCH Panel Kit
EUDAMEDClass C (EU MDR)
Ref 3B1272Ref 3B1271Ref 3B1271/C
Identity
- Trade Name
- TRUPCR® TORCH Panel Kit EUDAMED
- Device Name
- TRUPCR® TORCH Panel Kit EUDAMED
- Model / Reference
- 3B1272 EUDAMED3B1271 EUDAMED3B1271/C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908015304965 EUDAMED08908015304989 EUDAMED08908015304958 EUDAMED
- Basic UDI-DI
- 89080153043B1271L7 EUDAMED
- EMDN Code
- W0105070302 OTHER VIRUS COMBINATIONS - 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® TORCH 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 | 89080153043B1271L7 | 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 b82d6f1c-5d14-46fd-9865-d6ac065385b4 61 fields · synced Jul 30, 2026
- EUDAMED c50a941d-10f5-405a-8a60-b7a1ef95e1a3 61 fields · synced May 17, 2026
- EUDAMED 646f6e26-2ec7-4e55-a105-0390b1f2183c 61 fields · synced May 18, 2026