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<eudamedExport entity="devices">
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    <udiDi>D-8844342-20AV</udiDi>
    <basicUdiDi>B-8844342-20AV</basicUdiDi>
    <tradeName>KMRtrack® KMR020</tradeName>
    <deviceName>KMRtrack® KMR020</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>8844342-20</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:21.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-28BD</udiDi>
    <basicUdiDi>B-8844342-28BD</basicUdiDi>
    <tradeName>KMRtrack® KMR028</tradeName>
    <deviceName>KMRtrack® KMR028</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>8844342-28</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:21.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-19BC</udiDi>
    <basicUdiDi>B-8844342-19BC</basicUdiDi>
    <tradeName>KMRtrack® KMR019</tradeName>
    <deviceName>KMRtrack® KMR019</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>8844342-19</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:21.329Z</lastUpdated>
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  <row>
    <udiDi>D-8844342-17B8</udiDi>
    <basicUdiDi>B-8844342-17B8</basicUdiDi>
    <tradeName>KMRtrack® KMR017</tradeName>
    <deviceName>KMRtrack® KMR017</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>8844342-17</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:15.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-16B6</udiDi>
    <basicUdiDi>B-8844342-16B6</basicUdiDi>
    <tradeName>KMRtrack® KMR016</tradeName>
    <deviceName>KMRtrack® KMR016</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>8844342-16</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:14.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-14B2</udiDi>
    <basicUdiDi>B-8844342-14B2</basicUdiDi>
    <tradeName>KMRtrack® KMR014</tradeName>
    <deviceName>KMRtrack® KMR014</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>8844342-14</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:13.743Z</lastUpdated>
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  <row>
    <udiDi>D-8844342-13AY</udiDi>
    <basicUdiDi>B-8844342-13AY</basicUdiDi>
    <tradeName>KMRtrack® KMR013</tradeName>
    <deviceName>KMRtrack® KMR013</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>8844342-13</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:13.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-09B9</udiDi>
    <basicUdiDi>B-8844342-09B9</basicUdiDi>
    <tradeName>KMRtrack® KMR009</tradeName>
    <deviceName>KMRtrack® KMR009</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>8844342-09</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:08.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-04AX</udiDi>
    <basicUdiDi>B-8844342-04AX</basicUdiDi>
    <tradeName>KMRtrack® KMR004</tradeName>
    <deviceName>KMRtrack® KMR004</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>8844342-04</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:07.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-11AU</udiDi>
    <basicUdiDi>B-8844342-11AU</basicUdiDi>
    <tradeName>KMRtrack® KMR011</tradeName>
    <deviceName>KMRtrack® KMR011</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>8844342-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:07.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-10AS</udiDi>
    <basicUdiDi>B-8844342-10AS</basicUdiDi>
    <tradeName>KMRtrack® KMR010</tradeName>
    <deviceName>KMRtrack® KMR010</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>8344342-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:28:06.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88429825A</udiDi>
    <basicUdiDi>B-88429825A</basicUdiDi>
    <tradeName>KMRtrack® Monitoring Kit</tradeName>
    <deviceName>KMRtrack® Monitoring Kit</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>8842982</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:48.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88417814P</udiDi>
    <basicUdiDi>B-88417814P</basicUdiDi>
    <tradeName>KMRtype® Genotyping Kit</tradeName>
    <deviceName>KMRtype Genotyping Kit</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>8841781</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:47.874Z</lastUpdated>
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  <row>
    <udiDi>88000214000009</udiDi>
    <basicUdiDi>B-88000214000009</basicUdiDi>
    <tradeName>88000214000009</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DCGen Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026351</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DCOF</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:23:13.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>8681957090034DQ</udiDi>
    <basicUdiDi>B-8681957090034DQ</basicUdiDi>
    <tradeName>MULTIGEN</tradeName>
    <deviceName>Yeni Nesil Dizi Analizi ile BRCA1 ve BRCA2 Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-BR-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T12:41:53.353Z</lastUpdated>
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  <row>
    <udiDi>D-86804222814035R</udiDi>
    <basicUdiDi>B-86804222814035R</basicUdiDi>
    <tradeName>IntRaFast-Q SMA SCREENING KIT</tradeName>
    <deviceName>IntRaFast-Q SMA SCREENING KIT</deviceName>
    <manufacturerName>SNP BİYOTEKNOLOJİ ARAŞTIRMA GELİŞTİRME VE ÜRETİM SANAYİ VE TİCARET LİMİTED ŞİRKETİLİMİTED</manufacturerName>
    <manufacturerSrn>TR-MF-000036548</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200R-40-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T08:18:27.325Z</lastUpdated>
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    <udiDi>D-8437025247GEUSLBC7</udiDi>
    <basicUdiDi>B-8437025247GEUSLBC7</basicUdiDi>
    <tradeName>GEUS-LB®</tradeName>
    <deviceName>GEUS-LB</deviceName>
    <manufacturerName>ANILING SL</manufacturerName>
    <manufacturerSrn>ES-MF-000025687</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEUS-LB®</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:16:06.066Z</lastUpdated>
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  <row>
    <udiDi>D-8437025247GEUSCRCPD</udiDi>
    <basicUdiDi>B-8437025247GEUSCRCPD</basicUdiDi>
    <tradeName>GEUS-CRC®</tradeName>
    <deviceName>GEUS-CRC</deviceName>
    <manufacturerName>ANILING SL</manufacturerName>
    <manufacturerSrn>ES-MF-000025687</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEUS-CRC®</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:16:03.558Z</lastUpdated>
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    <udiDi>D-8437025247GEUS5Q</udiDi>
    <basicUdiDi>B-8437025247GEUS5Q</basicUdiDi>
    <tradeName>GEUS-CLL®</tradeName>
    <deviceName>GEUS-CLL</deviceName>
    <manufacturerName>ANILING SL</manufacturerName>
    <manufacturerSrn>ES-MF-000025687</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEUS-CLL®</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:16:01.156Z</lastUpdated>
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    <udiDi>D-84295773154WTGK</udiDi>
    <basicUdiDi>B-84295773154WTGK</basicUdiDi>
    <tradeName>HLA B27 Strip</tradeName>
    <deviceName>HLA B27 Strip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.154.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:30.941Z</lastUpdated>
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