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PerQseal® Elite

by Vivasure Medical Ltd. Ireland EUDAMED

Ref DP4-P1-2-G, DP4-FA1-2-GModel DP4-P1-2, DP4-FA1-2 EMDN C900199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539153318DP4P1PPC9 Basic UDI-DIDate26 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
PerQseal® Elite
PerQseal® Elite Introducer
Model / Reference
DP4-P1-2, DP4-P1-2-G, DP4-FA1-2, DP4-FA1-2-G
Primary DI / UDI-DI
05391533180433, 05391533180396
Basic UDI-DI
539153318DP4P1PPC9, 539153318DP4FA1INTV7
EMDN Code
C900199, C0502
Device Class
Class III
Class IIa
Market of Registration
Germany
Medical Purpose
The PerQseal Elite Closure Device is intended for percutaneous common femoral access site closure following interventional therapeutic endovascular procedures.

Manufacturer details

EUDAMED SRN
IE-PR-000011259

Other devices from Vivasure Medical Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile NoEUDAMEDYesEUDAMED
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 (2)

  • EUDAMED 437e7c72-db60-4587-b929-127da2964168 61 fields · synced 25 Oct 2026
  • EUDAMED 05391533180396|539153318DP4FA1INTV7 61 fields · synced 18 May 2026