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pRESET STANDARD Thrombectomy Device

by phenox GmbH Germany EUDAMED

Ref PRE-6-30Model Thrombectomy Systems

EMDN C010402020702

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000332692 Date4 Sep 2026IssuedStatusActive expires 20 Dec 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000334607 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 0297
    Issued
    4 Sep 2026
    Expires
    21 Mar 2029
    Reason
    Change approved
  • 1000332692 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    4 Sep 2026
    Expires
    20 Dec 2028
    Reason
    Change approved

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Thrombectomy Systems, PRE-6-30
Primary DI / UDI-DI
04260123784119
Basic UDI-DI
426012378ThrombectomyF6
EMDN Code
C010402020702 Mechanical peripheral thrombectomy and thromboaspiration systems
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006524

Other devices from phenox GmbH

See all devices from phenox GmbH →

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 542604f3-734b-4f19-bc80-70b0a71109f5 61 fields · synced 22 Oct 2026