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Palm Brace

by Welsheng Corp. 2 variants

Ref 605-R-WT-S-1, 605-L-WT-M-1, 605-L-WT-S-1, 605-L-WT-XL-1, 605-R-WT-M-1, 605-R-WT-XL-1, 605-L-WT-L-1

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

Overview

A comprehensive medical device directory listing for the Palm Brace.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471988489CL103GL Basic UDI-DI Date4 Sep 2023RegisteredStatusActive

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  • Withdrawn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
Upper Extremity Orthoses
Model / Reference
605-R-WT-S-1, 605-L-WT-M-1, 605-L-WT-S-1, 605-L-WT-XL-1, 605-R-WT-M-1, 605-R-WT-XL-1, 605-L-WT-L-1
Primary DI / UDI-DI
04719884892385, 04719884892415, 04719884892392, 04719884892453, 04719884892408, 04719884892446, 04719884892439
Basic UDI-DI
471988489CL103GL
EMDN Code
Y060699 Orthoses, upper extremity - other
Device Class
Class I
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
TW-MF-000005197
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Welsheng Corp.

See all devices from Welsheng Corp. →

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