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<eudamedExport entity="devices">
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    <udiDi>00850017493124</udiDi>
    <basicUdiDi>0850017493A011248A</basicUdiDi>
    <tradeName>AmplideX Fragile X Dx &amp; Carrier Screen Kit</tradeName>
    <deviceName>AmplideX Fragile X Dx &amp; Carrier Screen Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A01124</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:15:37.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-10106010104029X2</udiDi>
    <basicUdiDi>B-10106010104029X2</basicUdiDi>
    <tradeName>D-10106010104029X2</tradeName>
    <deviceName>FMR1 CGG PCR</deviceName>
    <manufacturerName>Beijing Healthgene Laboratory Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032465</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:37:26.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942307</udiDi>
    <basicUdiDi>B-08437016942307</basicUdiDi>
    <tradeName>Adellgene® Fragile X Screening 48 tests</tradeName>
    <deviceName>Adellgene® Fragile X Screening 48 tests</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-FX-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:27.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942291</udiDi>
    <basicUdiDi>B-08437016942291</basicUdiDi>
    <tradeName>Adellgene® Fragile X Screening 16 tests</tradeName>
    <deviceName>Adellgene® Fragile X Screening 16 tests</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-FX-16</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:23.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358885019</udiDi>
    <basicUdiDi>B-06975358885019</basicUdiDi>
    <tradeName>06975358885019</tradeName>
    <deviceName>PCR-CE FMR1 Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:28.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358885002</udiDi>
    <basicUdiDi>B-06975358885002</basicUdiDi>
    <tradeName>06975358885002</tradeName>
    <deviceName>PCR-CE FMR1 Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:27.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850017493049</udiDi>
    <basicUdiDi>B-00850017493049</basicUdiDi>
    <tradeName>AmplideX mPCR FMR1 Test</tradeName>
    <deviceName>AmplideX mPCR FMR1 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>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A00401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:20.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-00106010104013V8</udiDi>
    <basicUdiDi>B-00106010104013V8</basicUdiDi>
    <tradeName>D-00106010104013V8</tradeName>
    <deviceName>FMR1 CGG PCR</deviceName>
    <manufacturerName>Beijing Healthgene Laboratory Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032465</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:10:46.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942475</udiDi>
    <basicUdiDi>8437016942AD-FMR178</basicUdiDi>
    <tradeName>Adellgene® Fragile X 100 tests</tradeName>
    <deviceName>Adellgene® Fragile X</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>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-FMR1-100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:37.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942468</udiDi>
    <basicUdiDi>8437016942AD-FMR178</basicUdiDi>
    <tradeName>Adellgene® Fragile X 25 tests</tradeName>
    <deviceName>Adellgene® Fragile X</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>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-FMR1-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:36.517Z</lastUpdated>
  </row>
</eudamedExport>