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RX Herculink Elite™ Peripheral Stent System

by Abbott Medical EUDAMED

Expiring European Union

Ref 1011536-12

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717648PBS0002YK Basic UDI-DIDate17 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 755160 Expiring Amended Expires in 266 days

    Technical documentation EU MDR

    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
1011536-12
Primary DI / UDI-DI
08717648084911
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

Other devices from Abbott Medical

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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