Hematology Control
by Shenzhen Dymind Biotechnology Co., Ltd. China EUDAMED
Ref XQ-0091-05Model Model:DM-6DR , Specification:2mL（H）×2, Model:DM-6DR,Specification：3mL（L）×1+3mL（N）×1+ 3mL（H）×1、2mL（L）×1+2mL（N）×1+ 2mL（H）×1
EMDN W0103010503
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-06941377307146 | Date4 Jul 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-06941377307146 | Date4 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Model / Reference
- Model:DM-6DR, Specification:2mL（H）×2, XQ-0091-05, Specification：3mL（L）×1+3mL（N）×1+ 3mL（H）×1、2mL（L）×1+2mL（N）×1+ 2mL（H）×1
- Primary DI / UDI-DI
- 06941377307146
- Basic UDI-DI
- B-06941377307146, 697049309W01033013001CB
- Direct Marketing DI
- 06941377307146
- EMDN Code
- W0103010503 Multilevel blood controls
- Device Class
- Class IVD GeneralClass B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000024842
- Authorised representative
- Eunitor GmbH DE-AR-000005081
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Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED 06941377307146|B-06941377307146
- EUDAMED 06941377307146|697049309W01033013001CB