Diluent
by Dirui Industrial Co., Ltd China EUDAMED
Ref 3019939
EMDN W0103010105
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69257945W0103010105R0LU | Date26 Jul 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Hematology Reagent
- Model / Reference
- 3019939
- Primary DI / UDI-DI
- 06925794577931
- Basic UDI-DI
- 69257945W0103010105R0LU
- EMDN Code
- W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000001891
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Dirui Industrial 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
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 06925794577931|69257945W0103010105R0LU