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GORE® TIGRIS® Vascular Stent

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

Ref PHB050802

EMDN P070402020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00733132608850 Basic UDI-DIDate3 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
PHB050802
Primary DI / UDI-DI
00733132608850
Basic UDI-DI
B-00733132608850
EMDN Code
P070402020199 Peripheral vascular bare stents - other
Device Class
Class III

Manufacturer details

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

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • Animal Tissues
  • Administering Medicine
  • Incorporates Medicinal Product
Other properties (8)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No

Sources (1)

  • EUDAMED 06dd8d66-3139-407e-aabb-4e7b834f568c 61 fields · synced 22 Oct 2026