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Tess Back

by Shonaquip (Pty) Ltd 36 variants

Ref TESS BACK 12” (TB12-3415A)

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 Number6009803836TESS-SQRD Basic UDI-DI 06009803836179UDI-DIDate15 Aug 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier 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  • Withdrawn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
Tess Back
Model / Reference
TESS BACK 12” (TB12-3415A)
Primary DI / UDI-DI
06009803836179
Basic UDI-DI
6009803836TESS-SQRD
EMDN Code
Y121821 Retractors, backrests, brackets and supports
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
ZA-MF-000036950
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Shonaquip (Pty) Ltd

See all devices from Shonaquip (Pty) Ltd →

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