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<eudamedExport entity="devices">
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    <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>
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  <row>
    <udiDi>08437016942451</udiDi>
    <basicUdiDi>8437016942GVS-FIIQP</basicUdiDi>
    <tradeName>Genvinset® Factor II G20210A 48 test</tradeName>
    <deviceName>Genvinset® Factor II G20210A</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>W0106010114</emdnCode>
    <emdnDescription>PROTHROMBIN MUTATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FII-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:34.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942444</udiDi>
    <basicUdiDi>8437016942GVS-FIIQP</basicUdiDi>
    <tradeName>Genvinset® Factor II G20210A 24 test</tradeName>
    <deviceName>Genvinset® Factor II G20210A</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>W0106010114</emdnCode>
    <emdnDescription>PROTHROMBIN MUTATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FII-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:32.818Z</lastUpdated>
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    <udiDi>08437016942437</udiDi>
    <basicUdiDi>8437016942AD-SCA2A</basicUdiDi>
    <tradeName>Adellgene® SCAs 16 tests</tradeName>
    <deviceName>Adellgene® SCAs</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>W0106010113</emdnCode>
    <emdnDescription>SPIHOCEREBELLAR ATAXINS TYPE 1,2,3,6,7,8</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-SCA-16</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:26.813Z</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>
  <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>
  <row>
    <udiDi>08437016942345</udiDi>
    <basicUdiDi>8437016942AD-MDCZG</basicUdiDi>
    <tradeName>Adellgene® Myotonic Dystrophy Confirmatory 16 tests</tradeName>
    <deviceName>Adellgene® Myotonic Dystrophy Confirmatory</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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-MD-C-16</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:23.205Z</lastUpdated>
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  <row>
    <udiDi>08437016942208</udiDi>
    <basicUdiDi>8437016942GVS-S65CZR</basicUdiDi>
    <tradeName>Genvinset® HFE S65C 48 tests</tradeName>
    <deviceName>Genvinset® HFE S65C</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>W0106010105</emdnCode>
    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-S65C-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:17.198Z</lastUpdated>
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  <row>
    <udiDi>08437016942192</udiDi>
    <basicUdiDi>8437016942GVS-S65CZR</basicUdiDi>
    <tradeName>Genvinset® HFE S65C 24 tests</tradeName>
    <deviceName>Genvinset® HFE S65C</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>W0106010105</emdnCode>
    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-S65C-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:16.003Z</lastUpdated>
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    <udiDi>08437016942161</udiDi>
    <basicUdiDi>8437016942GVS-NPF7</basicUdiDi>
    <tradeName>Genvinset® HLA Narcolepsy 48 tests</tradeName>
    <deviceName>Genvinset® HLA Narcolepsy</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>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-NP-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:14.901Z</lastUpdated>
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  <row>
    <udiDi>08437016942154</udiDi>
    <basicUdiDi>8437016942GVS-NPF7</basicUdiDi>
    <tradeName>Genvinset® HLA Narcolepsy 24 tests</tradeName>
    <deviceName>Genvinset® HLA Narcolepsy</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>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-NP-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:12.398Z</lastUpdated>
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    <udiDi>08437016942123</udiDi>
    <basicUdiDi>8437016942GVS-A29LW</basicUdiDi>
    <tradeName>Genvinset® HLA A29 48 tests</tradeName>
    <deviceName>Genvinset® HLA A29</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>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-A29-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:06.392Z</lastUpdated>
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  <row>
    <udiDi>08437016942116</udiDi>
    <basicUdiDi>8437016942GVS-A29LW</basicUdiDi>
    <tradeName>Genvinset® HLA A29 24 tests</tradeName>
    <deviceName>Genvinset® HLA A29</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>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-A29-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:05.280Z</lastUpdated>
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  <row>
    <udiDi>08437016942109</udiDi>
    <basicUdiDi>8437016942GVS-DQEB</basicUdiDi>
    <tradeName>Genvinset® HLA Celiac 48 tests</tradeName>
    <deviceName>Genvinset® HLA Celiac</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>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DQ-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:03.996Z</lastUpdated>
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    <udiDi>08437016942093</udiDi>
    <basicUdiDi>8437016942GVS-DQEB</basicUdiDi>
    <tradeName>Genvinset® HLA Celiac 24 tests</tradeName>
    <deviceName>Genvinset® HLA Celiac</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>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DQ-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:35:02.806Z</lastUpdated>
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    <udiDi>08437013457279</udiDi>
    <basicUdiDi>8437013457Gentest002QM</basicUdiDi>
    <tradeName>ID HPA XT Reagents</tradeName>
    <deviceName>ID HPA XT</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010220034</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:14.764Z</lastUpdated>
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    <udiDi>08437013457101</udiDi>
    <basicUdiDi>8437013457Gentest001QK</basicUdiDi>
    <tradeName>A1AT Genotyping Test Reagents</tradeName>
    <deviceName>A1AT Genotyping Test</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1292320000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:13.568Z</lastUpdated>
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    <udiDi>08437013457095</udiDi>
    <basicUdiDi>8437013457Gentest001QK</basicUdiDi>
    <tradeName>A1AT Genotyping Test Reagents</tradeName>
    <deviceName>A1AT Genotyping Test</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1292380000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:12.371Z</lastUpdated>
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    <udiDi>08436615250073</udiDi>
    <basicUdiDi>843661525GVS-THPUG</basicUdiDi>
    <tradeName>Genvinset® Thrombo panel 96 test</tradeName>
    <deviceName>Genvinset® Thrombo panel</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>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-THP-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:11.163Z</lastUpdated>
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    <udiDi>08436615250066</udiDi>
    <basicUdiDi>843661525GVS-THPUG</basicUdiDi>
    <tradeName>Genvinset® Thrombo panel 48 test</tradeName>
    <deviceName>Genvinset® Thrombo panel</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>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-THP-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:05.157Z</lastUpdated>
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