TRUPCR® UTI ID Panel Kit
by 3B BlackBio Dx Limited India EUDAMED
Ref 3B319/C EMDN W0104080607
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number8906213933B319YU | Date22 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 3B319/C
- Primary DI / UDI-DI
- 08906213930245
- Basic UDI-DI
- 8906213933B319YU
- EMDN Code
- W0104080607 Nucleic acid identification - manual / automated other resistance markers
- 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: ALL Panel
Other devices from 3B BlackBio Dx Limited
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 08906213930245|8906213933B319YU