Human Papillomavirus (HPV) Typing Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method)
by Bgi Europe a/S Denmark EUDAMED
Ref MFG030021Model 4800T EMDN W0105041004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05745000468027 | Date26 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Human Papillomavirus (HPV) Typing Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method)
- Model / Reference
- 4800T, MFG030021
- Primary DI / UDI-DI
- 05745000468027
- Basic UDI-DI
- B-05745000468027
- EMDN Code
- W0105041004 Full genotyping high-risk + low-risk hpv - na reagents
- Device Class
- Class IVD General
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000014089
Other devices from Bgi Europe a/S
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED e83664a2-d366-4ba0-bb1b-3fd1ed1c7873