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Tr Spine

by Ck Grup Tibbi̇ Malzemeler İnşaat Taahhüt Turi̇zm Taşimacilik Temi̇zli̇k Gida Teksti̇l Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 1,000+ variants

Ref TRMHSS5035

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-08680539121517 Basic UDI-DI 08680539121517UDI-DIDate10 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
PEDINOVA MONOAXIAL REDUCTION PEDICLE SCREW 5.0x35MM
Model / Reference
TRMHSS5035
Primary DI / UDI-DI
08680539121517
Basic UDI-DI
B-08680539121517
EMDN Code
P09070302 Thoracolumbosacral fixation systems
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026734

Other devices from Ck Grup Tibbi̇ Malzemeler İnşaat Taahhüt Turi̇zm Taşimacilik Temi̇zli̇k Gida Teksti̇l Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Ck Grup Tibbi̇ Malzemeler İnşaat Taahhüt Turi̇zm Taşimacilik Temi̇zli̇k Gida Teksti̇l Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

  • Implantable

Other properties (10)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No