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CTi® Custom

by Össur Iceland ehf. Iceland EUDAMED

Ref B-118500010Model BU00018

EMDN Y061209

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5690967BU00018NC 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 24 Oct 2026

Model / Reference
BU00018, B-118500010
Primary DI / UDI-DI
05690977195417
Basic UDI-DI
5690967BU00018NC
EMDN Code
Y061209 Knee 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 05690977195417|5690967BU00018NC 61 fields · synced 24 Oct 2026