Dimension Vista CYSC Flex reagent cartridge
by Siemens Healthcare Diagnostics Products GmbH FDA registration: Germany EUDAMED
Ref 10709558Model IVDR_67_MAR EB_C_KIT_V_CYSC EMDN W0102019008
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number0405686902049VF | Date10 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- IVDR_67_MAR Eb_c_kit_v_cysc
- Model / Reference
- IVDR_67_MAR EB_C_KIT_V_CYSC, 10709558
- Primary DI / UDI-DI
- 00842768037399
- Basic UDI-DI
- 0405686902049VF
- Unit of Use DI
- 00630414324043
- EMDN Code
- W0102019008 Cystatin c
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005039
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Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 00842768037399|0405686902049VF