Flow Cytometer(CytoFLUX310)
by Chengdu Legend-Tec Technology Co., Ltd China EUDAMED
Ref 085
EMDN W02020499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697735700031LZ | Date17 Apr 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Flow Cytometer
- Model / Reference
- 085
- Primary DI / UDI-DI
- 06977357000851
- Basic UDI-DI
- 697735700031LZ
- EMDN Code
- W02020499 Flow cytometry instruments - other
- Device Class
- Class A
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000047100
- Authorised representative
- GRZAN GROUP SL ES-AR-000039086
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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 fd0acadb-9c0b-45e2-a6bc-30ee0ed76f08