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DynamX Sirolimus Eluting Coronary Bioadaptor System

by Elixir Medical Corporation 61 variants

Ref VIR3538Model VIR2014

Active European Union

CE MDR

Valid until

8 Nov 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081750801DynamXVIR4F Basic UDI-DI 00817508013087UDI-DIDate13 Nov 2025RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2025-MDR/QS-051 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Nov 2025
    Expires
    8 Nov 2029
  • 2025-MDR/TD-051 Active

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Nov 2025
    Expires
    8 Nov 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
VIR2014, VIR3538
Primary DI / UDI-DI
00817508013087
Basic UDI-DI
081750801DynamXVIR4F
EMDN Code
P07040199 Vascular endoprostheses - other
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
  • CMR Substance
  • Incorporates Medicinal Product

Other properties (9)

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