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DESyne® X2 Novolimus Eluting Coronary Stent System

EUDAMED

Class III (EU MDR)

Ref SZR2514, SZR2518, SZR2523, SZR2528, SZR2532, SZR2538, SZR2543, SZR2546, SZR2548

by Elixir Medical Corporation

Identity

Trade Name
DESyne® X2 Novolimus Eluting Coronary Stent System EUDAMED
Device Name
DESyne® X2 Novolimus Eluting Coronary Stent System EUDAMED
Model / Reference
SZR2514, SZR2518, SZR2523, SZR2528, SZR2532, SZR2538, SZR2543, SZR2546, SZR2548 EUDAMED

Identifiers

Primary DI / UDI-DI
D-SZR25XXF6 EUDAMED
Basic UDI-DI
B-SZR25XXF6 EUDAMED
EMDN Code
P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMED

Classification

Device Class
Class III EUDAMED
Market of Registration
Sweden EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

Yes

EUDAMED

DESyne® X2 Novolimus Eluting Coronary Stent System by Elixir Medical Corporation — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Elixir Medical Corporation
EUDAMED SRN
US-MF-000013041
Authorised Representative
Acorn Regulatory Consultancy Services Ltd IE-AR-000000592

Sources (2)

  • EUDAMED 8b47d3c5-bf48-433f-b237-366a8cc5e491-1 61 fields · synced Oct 6, 2026
  • EUDAMED 8b47d3c5-bf48-433f-b237-366a8cc5e491-2 61 fields · synced Jul 29, 2026