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Omni-Tract®

by Integra Lifesciences Corporation EUDAMED

Active European Union

Ref 11819

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10381780399490 Basic UDI-DIDate24 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

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.

Specification

EUDAMED

Device Name
Surgical Retractors and Retractor Systems
Model / Reference
11819
Primary DI / UDI-DI
10381780399490
Basic UDI-DI
B-10381780399490
EMDN Code
Z12019099 Various instruments for general and multidisciplinary surgery - other
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000025259
Authorised representative
Integra LifeSciences Services FR-AR-000002474

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

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