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Wingspan

by Stryker Neurovascular 15 variants

Ref WE035009Model 08858250000256RQ

Active European Union

CE MDR

Valid until

23 May 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 Number08858250000256RQ Basic UDI-DI 04546540702630UDI-DIDate1 Oct 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 739951 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    27 Feb 2024
    Expires
    23 May 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Wingspan Stent System
Model / Reference
08858250000256RQ, WE035009
Primary DI / UDI-DI
04546540702630
Basic UDI-DI
08858250000256RQ
EMDN Code
P070402010102 Metallic non-stainless steel coronary stents
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

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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