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Omnilink Elite™ Peripheral Stent System

by Abbott Medical Ireland EUDAMED

Ref 11003-39 EMDN P070402020102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717648PBS0001YH Basic UDI-DIDate17 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 759113 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    6 May 2025
    Expires
    21 Jul 2027
    Reason
    Other

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Peripheral Balloon Expaning Stent System, 0.035 in.
Model / Reference
11003-39
Primary DI / UDI-DI
08717648142444
Basic UDI-DI
8717648PBS0001YH
EMDN Code
P070402020102 Non-stainless steel peripheral vascular bare metal stents
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000003851
Authorised representative
Abbott Vascular International BE-AR-000002043

Other devices from Abbott Medical

See all devices from Abbott Medical →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • CMR Substance
Other properties (11)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08717648142444|8717648PBS0001YH 61 fields · synced 25 Oct 2026