Skip to content

Kopenhagen

by Florett GmbH EUDAMED

Active European Union

Ref 58908Model Genua; Malmö; Stockholm; Göteborg; Lugano; Genf; Dublin; Rijeka; Meran; Hamburg; Kokolla; Tromsö; Zürich; Vancouver; Rhodos; Dover; Rimini; Florenz; Parma; London; Belfast; Garmisch; Lindau; München; Innsbruck; Villach

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4040261therapieUE Basic UDI-DIDate12 Oct 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  • Withdrawn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

Device Name
Therapieschuhe
Model / Reference
Genua, Malmö, Stockholm, Göteborg, Lugano, Genf, Dublin, Rijeka, Meran, Hamburg, Kokolla, Tromsö, Zürich, Vancouver, Rhodos, Dover, Rimini, Florenz, Parma, London, Belfast, Garmisch, Lindau, München, Innsbruck, Villach, 58908
Primary DI / UDI-DI
04040261328464
Basic UDI-DI
4040261therapieUE
EMDN Code
Y063303 Ready-made orthotic shoes
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000012054

Other devices from Florett GmbH

See all devices from Florett 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