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Xtern Classic+ Foot Drop Orthotic Size Large

by Turbomed Orthotics inc. EUDAMED

Active European Union

Ref 101155-SA-L

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number62846468101155VZ Basic UDI-DIDate11 Mar 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Xtern Classic+ Foot Drop Orthotic
Model / Reference
101155-SA-L
Primary DI / UDI-DI
00628464680004, 00620553281734
Basic UDI-DI
62846468101155VZ, 62055328101155HQ
EMDN Code
Y06120602 Energy return ankle-foot orthoses
Device Class
Class I
Market of Registration
Austria
Sweden

Manufacturer details

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

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Properties

Show properties
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