Hematology Analysis Lytic Agent
by Zhejiang xinke Medical Technology Co., Ltd. China EUDAMED
Ref 06970293023526
EMDN W0599
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697029302lytic0013N | Date27 Jun 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Hematology Analysis Lytic Agent
- Model / Reference
- 06970293023526
- Primary DI / UDI-DI
- 06970293023526
- Basic UDI-DI
- 697029302lytic0013N
- EMDN Code
- W0599 IVD general use consumable devices - other
- Device Class
- Class A
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000032274
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
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Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- 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
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED e6a3059d-c4d5-42c1-828e-75954ba9b291