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Inspiron Sirolimus Eluting Stent

by Scitech Produtos Médicos SA Brazil EUDAMED

Ref 105194Model Inspiron Sirolimus Eluting Stent EMDN P070402010301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07908249700329 Basic UDI-DIDate8 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Inspiron Sirolimus Eluting Stent, 105194
Primary DI / UDI-DI
07908249700329
Basic UDI-DI
B-07908249700329
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
BR-MF-000018627
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Scitech Produtos Médicos SA

See all devices from Scitech Produtos Médicos SA →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 07908249700329|B-07908249700329 61 fields · synced 24 Oct 2026