Skip to content

Ortholox® UHMWPE Sternal Cerclage Band System (Ti. Locking- w/Sharp Needle) - 5.0 x 450mm

by Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

Ref 22-002-5450

Active European Union

CE MDR

Valid until

14 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number868232005SEBSH7 Basic UDI-DI 08682320051157UDI-DIDate16 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2026/0029 Active

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    15 Jun 2026
    Expires
    14 Jun 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
UHMWPE Band System - Sterile
Model / Reference
22-002-5450
Primary DI / UDI-DI
08682320051157
Basic UDI-DI
868232005SEBSH7
EMDN Code
P09120302 Cerclage devices, wires and binders
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000027137

Other devices from Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Ortolog Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

Properties

  • Sterile
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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