Northern Lights™-CLC
by Cytek Biosciences Inc. United States EUDAMED
Ref N7-00073, N7-00072Model NL-CLC
EMDN W0202040102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number0850037353NL-CLCSP | Date7 Nov 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- NL-CLC, N7-00073, N7-00072
- Primary DI / UDI-DI
- 00850037353651, 00850037353644
- Basic UDI-DI
- 0850037353NL-CLCSP
- EMDN Code
- W0202040102 Cytoflowmeters - moderate routine
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000032048
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Cytek Biosciences Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (2)
- EUDAMED 6d0d30cb-a96f-4bd2-981e-d00e9caa1295
- EUDAMED 3f3a2aef-e819-49f5-8542-658fb581adb2