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Ao-53U S/T

by Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇ EUDAMED

Active European Union

Ref AO-53U S/TModel ORTHOPEDICS BACK AND WAIST ORTHOSIS

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86803954ORT05X5 Basic UDI-DIDate9 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Orthopedics Back and Waist Orthosis
Model / Reference
ORTHOPEDICS BACK AND WAIST ORTHOSIS, AO-53U S/T
Primary DI / UDI-DI
08680395424616
Basic UDI-DI
86803954ORT05X5
Direct Marketing DI
08680395424616
EMDN Code
Y060318 Cervicothoracolumbosacral spine orthoses
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000046503

Other devices from Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇

See all devices from Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇ →

Properties

Show 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