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<eudamedExport entity="devices">
  <row>
    <udiDi>D-CT-PACxxxMQ</udiDi>
    <basicUdiDi>B-CT-PACxxxMQ</basicUdiDi>
    <tradeName>DNA in situ Hybridization Reagents</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CytoTest Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000054699</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT-PACxxx</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:33:06.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CT-LSPxxxV5</udiDi>
    <basicUdiDi>B-CT-LSPxxxV5</basicUdiDi>
    <tradeName>DNA in situ Hybridization Reagents</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CytoTest Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000054699</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT-LSPxxx</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:33:00.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CT-CCPxxxKY</udiDi>
    <basicUdiDi>B-CT-CCPxxxKY</basicUdiDi>
    <tradeName>DNA in situ Hybridization Reagents</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CytoTest Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000054699</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT-CCPxxx</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:32:59.839Z</lastUpdated>
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  <row>
    <udiDi>D-APOL1_80-061-00TX</udiDi>
    <basicUdiDi>B-APOL1_80-061-00TX</basicUdiDi>
    <tradeName>D-APOL1_80-061-00TX</tradeName>
    <deviceName>APOL1 Genotyping Test</deviceName>
    <manufacturerName>Laboratory Corporation of America Holdings</manufacturerName>
    <manufacturerSrn>US-MF-000017722</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-061-00</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:36:18.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9022B8</udiDi>
    <basicUdiDi>B-9022B8</basicUdiDi>
    <tradeName>D-9022B8</tradeName>
    <deviceName>Unique Dual Index Plate for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IDX096-U0X(X)-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:06.919Z</lastUpdated>
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  <row>
    <udiDi>D-8844342-57BL</udiDi>
    <basicUdiDi>B-8844342-57BL</basicUdiDi>
    <tradeName>KMRtrack® KMR057</tradeName>
    <deviceName>KMRtrack® KMR057</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-57</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:20.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-56BJ</udiDi>
    <basicUdiDi>B-8844342-56BJ</basicUdiDi>
    <tradeName>KMRtrack® KMR056</tradeName>
    <deviceName>KMRtrack® KMR056</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-56</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:19.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-55BG</udiDi>
    <basicUdiDi>B-8844342-55BG</basicUdiDi>
    <tradeName>KMRtrack® KMR055</tradeName>
    <deviceName>KMRtrack® KMR055</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-55</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:19.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-54BE</udiDi>
    <basicUdiDi>B-8844342-54BE</basicUdiDi>
    <tradeName>KMRtrack® KMR054</tradeName>
    <deviceName>KMRtrack® KMR054</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-54</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:15.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-53BC</udiDi>
    <basicUdiDi>B-8844342-53BC</basicUdiDi>
    <tradeName>KMRtrack® KMR053</tradeName>
    <deviceName>KMRtrack® KMR053</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>844342-53</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:14.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-52BA</udiDi>
    <basicUdiDi>B-8844342-52BA</basicUdiDi>
    <tradeName>KMRtrack® KMR052</tradeName>
    <deviceName>KMRtrack® KMR052</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>844342-52</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:13.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-51B8</udiDi>
    <basicUdiDi>B-8844342-51B8</basicUdiDi>
    <tradeName>KMRtrack® KMR051</tradeName>
    <deviceName>KMRtrack® KMR051</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-51</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:12.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-50B6</udiDi>
    <basicUdiDi>B-8844342-50B6</basicUdiDi>
    <tradeName>KMRtrack® KMR050</tradeName>
    <deviceName>KMRtrack® KMR050</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-50</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:08.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-49BM</udiDi>
    <basicUdiDi>B-8844342-49BM</basicUdiDi>
    <tradeName>KMRtrack® KMR049</tradeName>
    <deviceName>KMRtrack® KMR049</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-49</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:08.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-48BK</udiDi>
    <basicUdiDi>B-8844342-48BK</basicUdiDi>
    <tradeName>KMRtrack® KMR048</tradeName>
    <deviceName>KMRtrack® KMR048</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-48</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:07.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-47BH</udiDi>
    <basicUdiDi>B-8844342-47BH</basicUdiDi>
    <tradeName>KMRtrack® KMR047</tradeName>
    <deviceName>KMRtrack® KMR047</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-47</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:06.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-46BF</udiDi>
    <basicUdiDi>B-8844342-46BF</basicUdiDi>
    <tradeName>KMRtrack® KMR046</tradeName>
    <deviceName>KMRtrack® KMR046</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-46</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:47.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-45BD</udiDi>
    <basicUdiDi>B-8844342-45BD</basicUdiDi>
    <tradeName>KMRtrack® KMR045</tradeName>
    <deviceName>KMRtrack® KMR045</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-45</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:46.389Z</lastUpdated>
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  <row>
    <udiDi>D-8844342-44BB</udiDi>
    <basicUdiDi>B-8844342-44BB</basicUdiDi>
    <tradeName>KMRtrack® KMR044</tradeName>
    <deviceName>KMRtrack® KMR044</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-44</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:45.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-43B9</udiDi>
    <basicUdiDi>B-8844342-43B9</basicUdiDi>
    <tradeName>KMRtrack® KMR043</tradeName>
    <deviceName>KMRtrack® KMR043</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-43</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:44.774Z</lastUpdated>
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</eudamedExport>