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Fusion

by Concept Medical B.V. EUDAMED

Withdrawn No longer placed on the EU market

Ref EFN22532

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08720221013512 Basic UDI-DIDate11 Aug 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Withdrawn

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Fusion Sirolimus Eluting Coronary Stent System
Model / Reference
EFN22532
Primary DI / UDI-DI
08720221013512
Basic UDI-DI
B-08720221013512
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III

Manufacturer details

EUDAMED SRN
NL-MF-000011506

Other devices from Concept Medical B.V.

See all devices from Concept Medical B.V. →

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