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Shoulder Sleeve/Shoulder Support

by Irufa Industrial Group CO., LTD. 8 variants

Ref Shoulder-SF-21 Right XLModel Shoulder Support/ Shoulder Brace/ shoulder orthoses

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 Number471996166SHOULDERR5 Basic UDI-DI 04719961662412UDI-DIDate21 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  • Withdrawn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
Shoulder Support/ Shoulder Brace/Shoulder Wrap
Model / Reference
Shoulder Support/ Shoulder Brace/ shoulder orthoses, Shoulder-SF-21 Right XL
Primary DI / UDI-DI
04719961662412
Basic UDI-DI
471996166SHOULDERR5
EMDN Code
Y060621 Shoulder orthoses
Device Class
Class I
EU market of registration
Finland

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