<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08437016942352</udiDi>
    <basicUdiDi>8437016942AD-FAWG</basicUdiDi>
    <tradeName>Adellgene® Friedreich's Ataxia 16 tests</tradeName>
    <deviceName>Adellgene® Friedreich's Ataxia</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010112</emdnCode>
    <emdnDescription>FRIEDREICH'S ATAXIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-FA-16</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:24.406Z</lastUpdated>
  </row>
</eudamedExport>