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DESyne® X2 Novolimus Eluting Coronary Stent System

by Elixir Medical Corporation 55 variants

Ref SZR3518

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-SZR35189V Basic UDI-DI D-SZR35189VUDI-DIDate27 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
SZR3518
Primary DI / UDI-DI
D-SZR35189V
Basic UDI-DI
B-SZR35189V
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
US-MF-000013041
Authorised representative
Acorn Regulatory Consultancy Services Ltd IE-AR-000000592

Other devices from Elixir Medical Corporation

See all devices from Elixir Medical Corporation →

Properties

  • Sterile
  • Implantable
  • Incorporates Medicinal Product

Other properties (8)

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