CytoScan Analyzer
by ZKYH AImed Technology (Guangxi) Co., LTD. China EUDAMED
Ref Med-Auto Optics-200Model Med-Auto-Optics-200 Med-Auto-Optics-120 Med-Auto-Optics-80
EMDN W0202050301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697889490ZKYHCSAWK | Date15 Sep 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- CytoScan Analyzer
- Model / Reference
- Med-Auto-Optics-200 Med-Auto-Optics-120 Med-Auto-Optics-80, Med-Auto Optics-200
- Primary DI / UDI-DI
- 06978894900000
- Basic UDI-DI
- 697889490ZKYHCSAWK
- EMDN Code
- W0202050301 Electron microscopes
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000047063
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from ZKYH AImed Technology (Guangxi) Co., LTD.
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 6d19cf0a-a8a4-4bd4-a739-2c0e83d9105b