Skip to content

Flawless Motion Shoulder Brace

by Flawless Motion Ltd EUDAMED

Active European Union

Ref 28483Model Flawless Motion Shoulder Brace

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9421908914FMKE Basic UDI-DIDate9 Jun 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  • Withdrawn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
MultiDirectional
Model / Reference
Flawless Motion Shoulder Brace, 28483
Primary DI / UDI-DI
09421908914199
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

From the manufacturer

Manufacturer's product page: Women's Shoulder Braces

Other devices from Flawless Motion Ltd

See all devices from Flawless Motion Ltd →

Properties

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