CleanNGS Dx
by CleanNA B.V. Netherlands EUDAMED
Ref CNGS-0050CE, CNGS-0500CEModel CleanNGS Dx
EMDN W0105900101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number87202998087CNGS77 | Date5 Jun 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- CleanNGS Dx, CNGS-0050CE, CNGS-0500CE
- Primary DI / UDI-DI
- 08720299808751, 08720299808744
- Basic UDI-DI
- 87202998087CNGS77
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000022870
Other devices from CleanNA B.V.
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 (2)
- EUDAMED e278d778-fc6c-4a6f-a788-cd85091133ce
- EUDAMED 08720299808744|87202998087CNGS77