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Xtern Pediatric Foot Drop Orthotic

by Turbomed Orthotics inc. EUDAMED

Active European Union

Ref 100100-SA-P

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number62846468100100UZ 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  • Withdrawn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

Model / Reference
100100-SA-P
Primary DI / UDI-DI
00628464680097
Basic UDI-DI
62846468100100UZ
EMDN Code
Y06120602 Energy return ankle-foot orthoses
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

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