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PerQseal

by Vivasure Medical Ltd. Ireland EUDAMED

Ref DP2-FA1-5-G EMDN C0502

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539153318DP2FA1INTGDH Basic UDI-DIDate20 Sep 2023RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
PerQseal Introducer
Model / Reference
DP2-FA1-5-G
Primary DI / UDI-DI
05391533180228
Basic UDI-DI
539153318DP2FA1INTGDH
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IE-MF-000000651

Other devices from Vivasure Medical Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 342d6831-8508-4d3a-bebc-47dbd3c4a665 61 fields · synced 24 Oct 2026