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genXSync Sirolimus Eluting Coronary Stent System

by Purple MicroPort Cardiovascular Private Limited EUDAMED

Active European Union

Ref AC2.1 4.0016

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08904121808236 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
AC2.1 4.0016
Primary DI / UDI-DI
08904121808236
Basic UDI-DI
B-08904121808236
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
Market of Registration
Luxembourg

Manufacturer details

EUDAMED SRN
IN-MF-000028173
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Sterile
  • Implantable
  • Administering Medicine
  • Incorporates Medicinal Product

Other properties (7)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No