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by Turbomed Orthotics inc. Canada EUDAMED

Ref 201000-Y00-M EMDN Y061280

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number62055328200000GY Basic UDI-DIDate17 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Xtern Foot Drop Orthotics - Plastic Parts Replacement
Model / Reference
201000-Y00-M
Primary DI / UDI-DI
00620553281437
Basic UDI-DI
62055328200000GY
EMDN Code
Y061280 Lower limb orthoses - accessories
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
CA-MF-000032108
Authorised representative
OKO SOLUTION FR-AR-000006781

Other devices from Turbomed Orthotics inc.

See all devices from Turbomed Orthotics inc. →

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 7556145c-a1b5-4d46-ab77-473991c05c81 61 fields · synced 25 Oct 2026