<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09309003980007</udiDi>
    <basicUdiDi>9309003980GALEN_NAVJK</basicUdiDi>
    <tradeName>Galen AI Navigator</tradeName>
    <deviceName>Galen AI Navigator</deviceName>
    <manufacturerName>Indico Solutions Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000052693</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>GALEN-NAV-v1.0.0</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:04:17.282Z</lastUpdated>
  </row>
</eudamedExport>