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Spex

by Spex Ltd 1,000+ variants

Ref 1105-1716-0SH_060

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number94200517CUSHIONPP Basic UDI-DI 09420082611764UDI-DIDate3 May 2026RegisteredStatusActive

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  • Withdrawn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
Wheelchair Cushion
Model / Reference
1105-1716-0SH_060
Primary DI / UDI-DI
09420082611764
Basic UDI-DI
94200517CUSHIONPP
Direct Marketing DI
09420082611764
EMDN Code
Y122406 Belts, seats and armrests for wheelchairs
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
NZ-MF-000009327
Authorised representative
BEO MedConsulting Berlin GmbH DE-AR-000006764

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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