SaBella Flex Dual Axis Precision Positioning Overlay Only
by CDR Systems Inc. EUDAMED
Active
Ref SBS14-AP-AModel SBS14 SaBella Flex Series
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number62834193308J | Date21 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- SaBella Flex Dual Axis Precision Positioning Overlay Only
- Model / Reference
- SBS14 SaBella Flex Series, SBS14-AP-A
- Primary DI / UDI-DI
- 00628341930673
- Basic UDI-DI
- 62834193308J
- EMDN Code
- Z12011280 Patient positioning instruments - hardware accessories
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CA-MF-000051790
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from CDR Systems Inc
Properties
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