Human Papillomavirus Detection Kit (Multiplex Real-time PCR)
by Gold Probe Diagnostic Biotechnology Inc. MF China EUDAMED
Ref 600170 EMDN W0105041003
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06975977071701 | Date23 Jan 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Human Papillomavirus Detection Kit (Multiplex Real-time PCR)
- Model / Reference
- 600170
- Primary DI / UDI-DI
- 06975977071701
- Basic UDI-DI
- B-06975977071701
- EMDN Code
- W0105041003 Partial genotyping high-risk hpv - na reagents
- Device Class
- Class IVD General
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000031524
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 0ef28f0a-d548-44e7-8937-de8ff74511f8