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Comfort Wrist Brace

by Jiangsu Xiangyu Fitness Equipment Co., Ltd.

Ref B410

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698009614WB040EU Basic UDI-DI 06980096144281UDI-DIDate25 May 2026RegisteredStatusActive

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  • Withdrawn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
Deluxe Wrist Brace
Model / Reference
B410
Primary DI / UDI-DI
06980096144281
Basic UDI-DI
698009614WB040EU
EMDN Code
Y060613 Wrist-hand-fingers orthoses
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000054152
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Jiangsu Xiangyu Fitness Equipment Co., Ltd.

See all devices from Jiangsu Xiangyu Fitness Equipment 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