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RX Herculink Elite™ Peripheral Stent System

by Abbott Medical EUDAMED

Active European Union

Ref 1011528-18

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717648PBS0002YK 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  • Withdrawn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 755160 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    30 Apr 2025
    Expires
    21 Jul 2027
    Reason
    Other

Specification

EUDAMED

Device Name
Peripheral Balloon Expanding Stent System, 0.014 in.
Model / Reference
1011528-18
Primary DI / UDI-DI
08717648079078
Basic UDI-DI
8717648PBS0002YK
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

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Properties

  • 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