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ACCESS25™, 150cm, Straight Tip

by Penumbra, Inc.

Ref PXACSTRModel Vascular Microcatheter

Active European Union

CE MDR

Valid until

26 Mar 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 781037 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    22 Jun 2026
    Expires
    26 Mar 2029
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Penumbra Delivery Microcatheters
Model / Reference
Vascular Microcatheter, PXACSTR
Primary DI / UDI-DI
00815948029798
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