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MINI TREK™ Coronary Dilatation Catheter

by Abbott Medical Ireland EUDAMED

Ref 1012268-20 EMDN C010401020101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717648CDC0001LW Basic UDI-DIDate28 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  • Withdrawn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 762879 Restricted

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    10 Apr 2026
    Expires
    18 Apr 2028
    Reason
    Reduce scope

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Coronary Dilatation Catheter, RX, Semi-compliant
Model / Reference
1012268-20
Primary DI / UDI-DI
08717648138065
Basic UDI-DI
8717648CDC0001LW
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
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 & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
Other properties (11)
  • Implantable: No
  • 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

Sources (1)

  • EUDAMED 08717648138065|8717648CDC0001LW 61 fields · synced 25 Oct 2026