Pathology Slide Scanner
by Hangzhou Yipai Intelligent Technology Co., Ltd. China EUDAMED
Ref ML202304064001Model MDS-ML1080、MDS-ML360
EMDN W0202050303
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697601860scanner001LA | Date17 May 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- MDS-ML1080、MDS-ML360, ML202304064001
- Primary DI / UDI-DI
- 06976018600058
- Basic UDI-DI
- 697601860scanner001LA
- EMDN Code
- W0202050303 Optical laboratory microscopes
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000032711
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Hangzhou Yipai Intelligent Technology 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 65daaad5-5a3b-48a1-bc2c-76f776aee048