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Genua

by Florett GmbH EUDAMED

Active European Union

Ref 60928Model 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 28 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  • Withdrawn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, 60928
Primary DI / UDI-DI
04040261074293, 04040261074439, 04040261074255, 04040261132498, 04040261074446, 04040261074484, 04040261074453, 04040261074408, 04040261074460, 04040261074279, 04040261132504, 04040261132481, 04040261074309, 04040261074385, 04040261074354, 04040261074378, 04040261074316, 04040261074415, 04040261132474, 04040261074323, 04040261132542, 04040261132535, 04040261074330, 04040261074361, 04040261074477, 04040261132511, 04040261074262, 04040261074347, 04040261132528, 04040261074286, 04040261074392, 04040261074422
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