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Prostar™

by Abbott Medical EUDAMED

Active European Union

Ref 12322-02

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717648VCS000249 Basic UDI-DIDate28 Apr 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  • Withdrawn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 729160 Amended

    Technical documentation EU MDR

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

Specification

EUDAMED

Device Name
Suture-Mediated Closure, Prostar XL
Model / Reference
12322-02
Primary DI / UDI-DI
08717648013102
Basic UDI-DI
8717648VCS000249
EMDN Code
C90010303 Haemostasis systems with suture or clip systems
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

  • 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