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ACCESS25™, 150cm, 90° Tip

by Penumbra, Inc. EUDAMED

Active European Union

Ref PXAC090Model Vascular Microcatheter

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 781037 Date22 Jun 2026IssuedStatusActive expires 26 Mar 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 781037 Active Supplemented

    Technical documentation EU MDR

    Notified body
    2797
    Issued
    22 Jun 2026
    Expires
    26 Mar 2029
    Reason
    Other

Specification

EUDAMED

Device Name
Penumbra Delivery Microcatheters
Model / Reference
Vascular Microcatheter, PXAC090
Primary DI / UDI-DI
00815948029811
Basic UDI-DI
081454801PDMET
EMDN Code
C0104020202 Peripheral embolisation catheters and microcatheters
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000008514
Authorised representative
Penumbra Europe GmbH DE-AR-000004997

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Properties

  • Sterile

Other properties (12)

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