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Cast Shoe-S

by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇ EUDAMED

Active European Union

Ref ARF11-SML

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number868085310FOOTM2 Basic UDI-DIDate26 Nov 2024RegisteredStatusActive

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  • Withdrawn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
Foot Care
Model / Reference
ARF11-SML
Primary DI / UDI-DI
08680853105613
Basic UDI-DI
868085310FOOTM2
Direct Marketing DI
08680853105613
EMDN Code
T0208 Shoe covers (excluding personal protective equipment - PPE)
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000030874

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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