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Esprit™ BTK Everolimus Eluting Resorbable Scaffold System

by Abbott Medical EUDAMED

Active European Union

Ref 1213275-38

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717648DRS0001YM Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 809145 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    20 Aug 2026
    Expires
    14 Aug 2030
    Reason
    Add device or group

Specification

EUDAMED

Model / Reference
1213275-38
Primary DI / UDI-DI
08717648364884
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000003851
Authorised representative
Abbott Vascular International BE-AR-000002043

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