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Dynamic Scoliosis Orthosis

by Tedob Prodüksi̇yon Sağlik Ve Gida San. Ve Ti̇c. Ltd. Şti̇.

Ref YXSK01SModel Dynamic Scoliosis / Kyphosis Orthosis

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8683318800DBMY Basic UDI-DI 08685126711805UDI-DIDate22 Aug 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  • Withdrawn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

Model / Reference
Dynamic Scoliosis / Kyphosis Orthosis, YXSK01S
Primary DI / UDI-DI
08685126711805
Basic UDI-DI
8683318800DBMY
EMDN Code
Y060309 Thoracolumbosacral spine orthoses
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
TR-MF-000029627

Other devices from Tedob Prodüksi̇yon Sağlik Ve Gida San. Ve Ti̇c. Ltd. Şti̇.

See all devices from Tedob Prodüksi̇yon Sağlik Ve Gida San. Ve Ti̇c. Ltd. Şti̇. →

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