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X.ACT™ Carotid Stent System

by Abbott Medical EUDAMED

Active European Union

Ref XRX02007S

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717648CAR0002QW Basic UDI-DIDate26 Jun 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  • Withdrawn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 768949 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    27 May 2026
    Expires
    12 Jul 2028
    Reason
    Other

Specification

EUDAMED

Device Name
Carotid Stent System, X.ACT
Model / Reference
XRX02007S
Primary DI / UDI-DI
08717648007491
Basic UDI-DI
8717648CAR0002QW
EMDN Code
P070402020102 Non-stainless steel peripheral vascular bare metal stents
Device Class
Class III
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 (10)

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