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Unloader® Hip

by Össur Iceland ehf. Iceland EUDAMED

Ref B-465350038EModel BU00034

EMDN Y061215

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5690967BU00034NA Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
BU00034, B-465350038E
Primary DI / UDI-DI
05690977280540
Basic UDI-DI
5690967BU00034NA
EMDN Code
Y061215 Hip orthoses (including abduction orthoses)
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
IS-MF-000000173

Other devices from Össur Iceland ehf.

See all devices from Össur Iceland ehf. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED bde2e6ae-000a-4545-9887-555f356190ba 61 fields · synced 23 Oct 2026