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Upper Limbs brace

by Hengshui Tianjian Medical Supplies Co., Ltd EUDAMED

Active European Union

Ref TJ201Model TJ201,TJ201(1),TJ202,TJ202(1),TJ202(2),TJ202(3),TJ202(4),TJ203,TJ203(1),TJ204,TJ204(1),TJ205,TJ205(1),TJ205(2),TJ301,TJ301(1),TJ301(2),TJ301(3),TJ302,TJ302(1), etc

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697371228ULB001KF Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Upper Limbs brace
Model / Reference
TJ201, TJ201(1), TJ202, TJ202(1), TJ202(2), TJ202(3), TJ202(4), TJ203, TJ203(1), TJ204, TJ204(1), TJ205, TJ205(1), TJ205(2), TJ301, TJ301(1), TJ301(2), TJ301(3), TJ302, TJ302(1), etc
Primary DI / UDI-DI
06973712280678
Basic UDI-DI
697371228ULB001KF
EMDN Code
Y060680 Upper limb orthoses - accessories
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000016724
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hengshui Tianjian Medical Supplies 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