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OrthoPure XT Ligament Reconstruction Implant

by TRx Orthopaedics Limited EUDAMED

Active European Union

Ref 2406XTSModel 2405XTS

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506026002XT001WA Basic UDI-DIDate3 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 778429 Active

    Technical documentation EU MDR

    Notified body
    2797
    Issued
    29 May 2025
    Expires
    28 May 2030

Specification

EUDAMED

Device Name
OrthoPure XT Ligament Reconstruction Implant
Model / Reference
2405XTS, 2406XTS
Primary DI / UDI-DI
05060260020182
Basic UDI-DI
506026002XT001WA
EMDN Code
P0910 Ligament prostheses
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
GB-MF-000018091
Authorised representative
Advena Limited MT-AR-000000234

Other devices from TRx Orthopaedics Limited

Properties

  • Sterile
  • Implantable
  • Animal Tissues

Other properties (10)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No