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AXS Infinity LS

by Stryker Neurovascular 3 variants

Ref GEN-10476-80Model 08858251003505SU

Expiring European Union

CE MDR

Valid until

14 Oct 2027

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 Number08858251003505SU Basic UDI-DI 07613327298482UDI-DIDate22 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 736166 Expiring Expires in 349 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Oct 2022
    Expires
    14 Oct 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
AXS Infinity LS Long Sheath
Model / Reference
08858251003505SU, GEN-10476-80
Primary DI / UDI-DI
07613327298482
Basic UDI-DI
08858251003505SU
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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  • AXS Catalyst 6

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  • Trenza

    Class III

  • AXS Catalyst 5

    Class III

  • AXS Catalyst 7

    Class III

  • AXS Infinity LS

    Class III

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