Vivix-S 3643VR
by Vieworks Co., Ltd. South Korea EUDAMED
Ref FXRD-3643VRAWModel VIVIX-S 1717V, VIVIX-S 1751S, VIVIX-S 4386W, VIVIX-S VW Series, VIVIX-S FW Series, VIVIX-S VR Series EMDN Z11031180
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880939433VIVIXS1717V2Y | Date4 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Digital Imaging System
- Model / Reference
- VIVIX-S 1717V, VIVIX-S 1751S, VIVIX-S 4386W, FXRD-3643VRAW, VIVIX-S VW Series, VIVIX-S FW Series, VIVIX-S VR Series
- Primary DI / UDI-DI
- 08809394330814
- Basic UDI-DI
- 880939433VIVIXS1717V2Y, 880939433VIVIXSVW2H
- EMDN Code
- Z11031180 Systems for direct digital radiology (dr) - hardware accessories
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000020017
- Authorised representative
- Vieworks EU GmbH DE-AR-000052174
Other devices from Vieworks Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED 1150e6bf-b0a1-499b-b41c-2f2d91536a5d
- EUDAMED 08809394330814|880939433VIVIXSVW2H