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AXS Catalyst 7

by Stryker Neurovascular 3 variants

Ref IC068125AModel 08858250000255RN

Active European Union

CE MDR

Valid until

1 Mar 2028

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 Number08858250000255RN Basic UDI-DI 07613327417241UDI-DIDate25 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 736172 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    2 Mar 2023
    Expires
    1 Mar 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
AXS Catalyst Distal Access Catheter
Model / Reference
08858250000255RN, IC068125A
Primary DI / UDI-DI
07613327417241
Basic UDI-DI
08858250000255RN
EMDN Code
C0104040203 Neurovascular angiography guide catheters
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000002456
Authorised representative
Stryker European Operations Limited IE-AR-000000092

Other devices from Stryker Neurovascular

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    Class III

  • AXS Catalyst 7

    Class III

  • AXS Infinity LS

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See all devices from Stryker Neurovascular →

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