← Back to catalogue
TRUPCR® IDH1/2 Detection & Differentiation Kit
EUDAMEDClass C (EU MDR)
Ref 3B1337Model 3B1338
Identity
- Trade Name
- TRUPCR® IDH1/2 Detection & Differentiation Kit EUDAMED
- Device Name
- TRUPCR® IDH1/2 Detection & Differentiation Kit EUDAMED
- Model / Reference
- 3B1338 EUDAMED3B1337 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908015304255 EUDAMED08908015304033 EUDAMED
- Basic UDI-DI
- 89080153043B1338LE EUDAMED
- Direct Marketing DI
- 08908015304033 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMEDW0106010299 POLYGENETIC DISORDERS TESTS - 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® IDH1/2 Detection & Differentiation 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 | 89080153043B1338LE | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3B BlackBio Dx Limited
- EUDAMED SRN
- IN-MF-000023698
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED d4fdfb33-17f1-4b1e-ac4b-acc6bbd0798c 61 fields · synced Jul 28, 2026
- EUDAMED d635ec6a-3941-412f-b86a-1025ab530762 61 fields · synced May 17, 2026