Skip to content

GORE® ACUSEAL Vascular Graft

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

Ref ECH060010Model GORE® ACUSEAL Vascular Graft

EMDN P070102020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0733132200623942U Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 732282 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    31 Aug 2026
    Expires
    20 Feb 2027
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
GORE® ACUSEAL Vascular Graft, ECH060010
Primary DI / UDI-DI
00733132622566
Basic UDI-DI
0733132200623942U
EMDN Code
P070102020102 Ptfe vascular prostheses, straight, reinforced
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.

See all devices from W. L. Gore & Associates, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00733132622566|0733132200623942U 61 fields · synced 24 Oct 2026