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Hand And Wrist Brace

by Xiamen LongStar Medical Equipment Co., Ltd 95 variants

Ref FG-WR003 SModel FG-2001,FG-2026,FG-2005,FG-3021,FG-3007,FG-3011,FG-7014,FG-S007,FG-WR001,FG-WR002,FG-WR003,FG-WR003-1,FG-WR004,FG-WR004-1,FG-WR005,FG-WR006,FG-WR007,FG-WR007-1,FG-WR008,FG-WR008-1,FG-WR009,FG-WR010,FG-WR011,FG-WR012, etc.

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 Number697600995HAWBPQ Basic UDI-DI 06976009957406UDI-DIDate7 Jul 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  • Withdrawn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
Hand And Wrist Brace
Model / Reference
FG-2001, FG-2026, FG-2005, FG-3021, FG-3007, FG-3011, FG-7014, FG-S007, FG-WR001, FG-WR002, FG-WR003, FG-WR003-1, FG-WR004, FG-WR004-1, FG-WR005, FG-WR006, FG-WR007, FG-WR007-1, FG-WR008, FG-WR008-1, FG-WR009, FG-WR010, FG-WR011, FG-WR012, etc., FG-WR003 S
Primary DI / UDI-DI
06976009957406
Basic UDI-DI
697600995HAWBPQ
EMDN Code
Y090612 Arm and elbow protections
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000034315
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

From the manufacturer

Manufacturer's product page: Wrist Brace and thumb support

Other devices from Xiamen LongStar Medical Equipment Co., Ltd

See all devices from Xiamen LongStar Medical 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