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GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

by W. L. Gore & Associates, Inc. EUDAMED

Active European Union

Ref BXA057902EModel GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number07331322006847343 Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 732278 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    18 Jun 2026
    Expires
    20 Feb 2027
    Reason
    Other

Specification

EUDAMED

Model / Reference
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, BXA057902E
Primary DI / UDI-DI
00733132637775
Basic UDI-DI
07331322006847343
EMDN Code
P0704020204 Peripheral vascular stents, bioactive
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000001141
Authorised representative
W.L. Gore & Associates B.V. NL-AR-000000168

Other devices from W. L. Gore & Associates, Inc.

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Properties

Show properties
  • Sterile
  • Implantable
  • Animal Tissues
  • Incorporates Medicinal Product
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No