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TRUPCR® PML-RARA Kit - Quantitative
EUDAMEDClass C (EU MDR)
Ref 3B1259Ref 3B1260
Identity
- Trade Name
- TRUPCR® PML-RARA Kit - Quantitative EUDAMED
- Device Name
- TRUPCR® PML-RARA Kit - Quantitative EUDAMED
- Model / Reference
- 3B1259 EUDAMED3B1260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908015304538 EUDAMED08908015304545 EUDAMED
- Basic UDI-DI
- 89080153043B1259LH EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER 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® PML-RARA Kit - Quantitative 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 | 89080153043B1259LH | 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 (2)
- EUDAMED 1c31484b-4bea-499b-b719-1ade45d4271d 61 fields · synced Sep 17, 2026
- EUDAMED 3ba8253b-11fb-4f62-9324-0234944796ab 61 fields · synced May 18, 2026