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SaBella Flex Dual Axis Precision Positioning Overlay Only

by CDR Systems Inc. 16 variants

Ref SBS14-C2Model SBS14 SaBella Flex Series

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number62834193308J Basic UDI-DIDate21 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SaBella Flex Dual Axis Precision Positioning Overlay Only
Model / Reference
SBS14 SaBella Flex Series, SBS14-C2
Primary DI / UDI-DI
00628341930727
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

See all 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