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Lumbar brace

by Hengshui Tianjian Medical Supplies Co., Ltd EUDAMED

Active European Union

Ref TJ401Model TJ401,TJ401(1),TJ401(2),TJ402,TJ402(1), TJ402(2),TJ402(3),TJ402(4),TJ403,TJ403(1), TJ403(2),TJ403(3),TJ403(4),TJ404,TJ404(1), TJ404(2),TJ404(3),TJ404(4),TJ404(5),TJ405, TJ405(1),TJ405(2), etc

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697371228LB001CV 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  • Withdrawn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
Lumbar brace
Model / Reference
TJ401, TJ401(1), TJ401(2), TJ402, TJ402(1), TJ402(2), TJ402(3), TJ402(4), TJ403, TJ403(1), TJ403(2), TJ403(3), TJ403(4), TJ404, TJ404(1), TJ404(2), TJ404(3), TJ404(4), TJ404(5), TJ405, TJ405(1), TJ405(2), etc
Primary DI / UDI-DI
06973712281217
Basic UDI-DI
697371228LB001CV
EMDN Code
Y060306 Thoracolumbar orthoses
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