<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>00850017493032</udiDi>
    <basicUdiDi>B-00850017493032</basicUdiDi>
    <tradeName>AmplideX HTT SNP/Repeat Phasing Test</tradeName>
    <deviceName>AmplideX HTT SNP/Repeat Phasing Test</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010107</emdnCode>
    <emdnDescription>HUNTINGTON CHOREA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A00083</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:19.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942369</udiDi>
    <basicUdiDi>8437016942AD-HDWU</basicUdiDi>
    <tradeName>Adellgene® Huntington Disease 16 tests</tradeName>
    <deviceName>Adellgene® Huntington Disease</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>W0106010107</emdnCode>
    <emdnDescription>HUNTINGTON CHOREA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-HD-16</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:25.604Z</lastUpdated>
  </row>
</eudamedExport>