<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00827002566330</udiDi>
    <basicUdiDi>B-00827002566330</basicUdiDi>
    <tradeName>Formula 418®</tradeName>
    <deviceName>Formula 418® Vascular Balloon-Expandable Stent</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070402020101</emdnCode>
    <emdnDescription>STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOV418-18-80-3-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:58:05.175Z</lastUpdated>
  </row>
</eudamedExport>