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Kedley Back Supports

by Impo International Limited 4 variants

Ref KED063Model Kedley Support & Compression Range

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number60030580KED100VM Basic UDI-DI 06003058078384UDI-DIDate1 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  • Withdrawn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
Kedley Support & Compression Devices
Model / Reference
Kedley Support & Compression Range, KED063
Primary DI / UDI-DI
06003058078384
Basic UDI-DI
60030580KED100VM
EMDN Code
Y060308 Lumbosacral spine orthoses
Device Class
Class I
EU 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