TRUPCR® C-Kit Mutation Detection Kit
by 3B BlackBio Dx Limited India EUDAMED
Ref 3B1342 EMDN W01060299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number89080153043B1341L3 | Date27 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 3B1342
- Primary DI / UDI-DI
- 08906213930733
- Basic UDI-DI
- 89080153043B1341L3
- EMDN Code
- W01060299 Tests for acquired genetic or chromosomal alterations - other
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- IN-MF-000023698
- Authorised representative
- Wellkang Ltd XI-AR-000001836
From the manufacturer
Manufacturer's product page: C-KIT Mutation Detection
Other devices from 3B BlackBio Dx Limited
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 08906213930733|89080153043B1341L3