SA-20 Sampler Unit
by Sysmex Corporation Japan EUDAMED
Ref CM186605
EMDN W02029080
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number4987562XNsamplerunitND | Date29 Sep 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Sampler Unit
- Model / Reference
- CM186605
- Primary DI / UDI-DI
- 04987562434121
- Basic UDI-DI
- 4987562XNsamplerunitND
- EMDN Code
- W02029080 Various hematology / histology / cytology instruments - hardware accessories
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- JP-MF-000014037
- Authorised representative
- Sysmex Europe SE DE-AR-000022333
Other devices from Sysmex Corporation
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 (1)
- EUDAMED 04987562434121|4987562XNSAMPLERUNITND