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Shoulder&Arm Brace

by Xiamen Ortocare Sports Health Co., Ltd. China EUDAMED

Ref SH002Model AR001,AR002,AR003,AR004,AR005,AR006,AR007,CL001,CL002,CL003,CL003,SH001,SH002,SH003,SH004,SH005

EMDN Y090612

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697620010SAB0016A Basic UDI-DIDate30 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Shoulder&Arm Brace
Model / Reference
AR001, AR002, AR003, AR004, AR005, AR006, AR007, CL001, CL002, CL003, SH001, SH002, SH003, SH004, SH005
Primary DI / UDI-DI
06976200101257
Basic UDI-DI
697620010SAB0016A
EMDN Code
Y090612 Arm and elbow protections
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000034229
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Xiamen Ortocare Sports Health Co., Ltd.

See all devices from Xiamen Ortocare Sports Health Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 66e60165-da62-4243-a7d1-a027f098f298 61 fields · synced 24 Oct 2026