Landwind
by Shenzhen Landwind Biomedical Technology Co., Ltd. China EUDAMED
Ref 033Model L-65LEOⅠ, L-65LEOⅡ, L-65LH
EMDN W0103010105
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697489094LWBCR001PJ | Date20 Apr 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Hematology Analyzer Lyse
- Model / Reference
- L-65LEOⅠ, L-65LEOⅡ, L-65LH, 033
- Primary DI / UDI-DI
- 06974890940330
- Basic UDI-DI
- 697489094LWBCR001PJ
- EMDN Code
- W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
- Device Class
- Class A
Manufacturer details
- EUDAMED SRN
- CN-MF-000026781
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 09da6a6d-2a6c-441a-97fb-a69cf4e0f5be