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KarlaLuise

by GANTER Shoes GmbH EUDAMED

Active European Union

Ref 209977-5200Model Diabetic Protective Footwear

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9009211GanterDiabeticTK Basic UDI-DIDate12 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
Diabetic Protective Footwear, 209977-5200
Primary DI / UDI-DI
09010805224298, 09010805224274, 09010805224250, 09010805224304, 09010805224236, 09010805224281, 09010805224212, 09010805224205, 09010805224199, 09010805224229, 09010805224267, 09010805224328, 09010805224311, 09010805224243
Basic UDI-DI
9009211GanterDiabeticTK
EMDN Code
Y063303 Ready-made orthotic shoes
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AT-MF-000044022

Other devices from GANTER Shoes GmbH

See all devices from GANTER Shoes GmbH →

Properties

  • Animal Tissues

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No