<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>77094295747988</udiDi>
    <basicUdiDi>770999730956019B</basicUdiDi>
    <tradeName>SOFTWARE PARA SISTEMAS DE INFORMACIÓN Y GESTIÓN DE IMÁGENES RADIOLÓGICAS - HIRUKO</tradeName>
    <deviceName>SOFTWARE PARA SISTEMAS DE INFORMACIÓN Y GESTIÓN DE IMÁGENES RADIOLÓGICAS</deviceName>
    <manufacturerName>IMAGING EXPERTS AND HEALTHCARE SERVICES S.A.S</manufacturerName>
    <manufacturerSrn>CO-MF-000019356</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V92</emdnCode>
    <emdnDescription>MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HIRUKO</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:07:01.440Z</lastUpdated>
  </row>
</eudamedExport>