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MultiDirectional

by Flawless Motion Ltd New Zealand EUDAMED

Ref 28464Model Flawless Motion Shoulder Brace

EMDN Y060621

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9421908914FMKE Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
MultiDirectional
Model / Reference
Flawless Motion Shoulder Brace, 28464
Primary DI / UDI-DI
09413000139143
Basic UDI-DI
9421908914FMKE
EMDN Code
Y060621 Shoulder orthoses
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NZ-MF-000055869
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from Flawless Motion Ltd

See all devices from Flawless Motion Ltd →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 7e154278-75f1-4949-8aab-8f1b769e6d3f 61 fields · synced 22 Oct 2026