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Kedley Wrist Support

by Impo International Limited EUDAMED

Active European Union

Ref KED048Model Kedley Support & Compression Range

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number60030580KED100VM Basic UDI-DIDate1 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Kedley Support & Compression Devices
Model / Reference
Kedley Support & Compression Range, KED048
Primary DI / UDI-DI
06003058068484
Basic UDI-DI
60030580KED100VM
EMDN Code
Y060612 Wrist-hand orthoses
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000010073
Authorised representative
Eurolink Europe Compliance Limited IE-AR-000002852

Other devices from Impo International Limited

See all devices from Impo International Limited →

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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