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Wrist Sipport

by Irufa Industrial Group CO., LTD.

Ref WR-OS-17 Spacer FabricModel Wrist Splint/ Wrist sleeve/ Wrist support

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471996166UPPERTH Basic UDI-DI 04719961660319UDI-DIDate14 Feb 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Wrist Splint/ Wrist sleeve/ Wrist support/Wrist Brace
Model / Reference
Wrist Splint/ Wrist sleeve/ Wrist support, WR-OS-17 Spacer Fabric
Primary DI / UDI-DI
04719961660319
Basic UDI-DI
471996166UPPERTH
Direct Marketing DI
04719961660319
EMDN Code
Y060609 Wrist (forearm) orthoses
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
TW-MF-000046083
Authorised representative
KHANG BAO INTERNATIONAL KFT HU-AR-000034102

Other devices from Irufa Industrial Group CO., LTD.

See all devices from Irufa Industrial Group CO., 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