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StarClose SE™ Vascular Closure System

by Abbott Medical EUDAMED

Withdrawn Not intended for the EU market

Ref 14679

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 729100 Date15 Jul 2026IssuedStatusWithdrawn Not intended for the EU market expires 21 Jul 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 729100 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    15 Jul 2026
    Expires
    21 Jul 2027
    Reason
    Change approved

Specification

EUDAMED

Device Name
Clip Mediated Closure, StarClose SE
Model / Reference
14679
Primary DI / UDI-DI
08717648210327
Basic UDI-DI
8717648VCS00034B
EMDN Code
C90010303 Haemostasis systems with suture or clip systems
Device Class
Class IIb

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