MassLynx
by Waters Corporation United States EUDAMED
Ref 667007237DD
EMDN W020303
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number081677602MSTKPF0802BU | Date4 Oct 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Waters IVD Systems
- Model / Reference
- 667007237DD
- Primary DI / UDI-DI
- 00816776020681
- Basic UDI-DI
- 081677602MSTKPF0802BU
- EMDN Code
- W020303 Mass - spectrometry system
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000025801
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Waters Corporation
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 39a8db5e-f724-48fb-ab8d-3eb8ba904ddb