TRUPCR® Magbead Total Nucleic Acid Extraction Kit
by 3B BlackBio Dx Limited EUDAMED
Active
Ref 3B340
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number8906213933B339Z2 | Date3 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- 3B340
- Primary DI / UDI-DI
- 08906213931273
- Basic UDI-DI
- 8906213933B339Z2
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- 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
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