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Genua

by Florett GmbH EUDAMED

Active European Union

Ref 60919Model 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  • Withdrawn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, 60919
Primary DI / UDI-DI
04040261490024, 04040261475427, 04040261455870, 04040261455795, 04040261455917, 04040261455894, 04040261455726, 04040261455771, 04040261456112, 04040261503861, 04040261455849, 04040261475441, 04040261455962, 04040261503946, 04040261456136, 04040261475496, 04040261456020, 04040261455764, 04040261455863, 04040261503878, 04040261456044, 04040261455801, 04040261455610, 04040261475472, 04040261455993, 04040261456006, 04040261475458, 04040261489998, 04040261475434, 04040261455634, 04040261503830, 04040261456037, 04040261475564, 04040261455658, 04040261475588, 04040261456150, 04040261455603, 04040261490017, 04040261455627, 04040261455788, 04040261503809, 04040261455740, 04040261490123, 04040261489974, 04040261490055, 04040261456082, 04040261475571, 04040261490116, 04040261456143, 04040261503847
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