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Wrist Splint

by Irufa Industrial Group CO., LTD.

Ref WS-SF-23 LEFT S, WS-SF-23 LEFT SModel Irufa Wrist Brace/Wrist Splint/Wrist Support, 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-04719961660098 Basic UDI-DI 04719961660098UDI-DIDate15 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  • Withdrawn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 Brace/Wrist Splint/Wrist Support
Wrist Splint/ Wrist sleeve/ Wrist support/Wrist Brace
Model / Reference
Irufa Wrist Brace/Wrist Splint/Wrist Support, WS-SF-23 LEFT S, Wrist Splint/ Wrist sleeve/ Wrist support
Primary DI / UDI-DI
04719961660098
Basic UDI-DI
B-04719961660098, 471996166UPPERTH
EMDN Code
Y060699 Orthoses, upper extremity - other
Device Class
Class I
EU market of registration
Northern Ireland
Denmark

Manufacturer details

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

Other devices from Irufa Industrial Group CO., LTD.

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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