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    <basicUdiDi>B-08437016942376</basicUdiDi>
    <tradeName>Genvinset® Factor V G1691A 24 tests</tradeName>
    <deviceName>Genvinset® Factor V G1691A 24 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>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FV-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:29.575Z</lastUpdated>
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    <udiDi>08437016942338</udiDi>
    <basicUdiDi>B-08437016942338</basicUdiDi>
    <tradeName>Adellgene®  Myotonic Dystrophy Screening 16 tests</tradeName>
    <deviceName>Adellgene® Myotonic Dystrophy 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-MD-16</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:28.771Z</lastUpdated>
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    <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>
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    <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>
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  <row>
    <udiDi>08437016942222</udiDi>
    <basicUdiDi>B-08437016942222</basicUdiDi>
    <tradeName>Genvinset® HFE C282Y 48 tests</tradeName>
    <deviceName>Genvinset® HFE C282Y 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>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-C282Y-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:23.166Z</lastUpdated>
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  <row>
    <udiDi>08437016942215</udiDi>
    <basicUdiDi>B-08437016942215</basicUdiDi>
    <tradeName>Genvinset® HFE C282Y 24 tests</tradeName>
    <deviceName>Genvinset® HFE C282Y 24 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>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-C282Y-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:22.384Z</lastUpdated>
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  <row>
    <udiDi>08437016942185</udiDi>
    <basicUdiDi>B-08437016942185</basicUdiDi>
    <tradeName>Genvinset® HFE H63D 48 tests</tradeName>
    <deviceName>Genvinset® HFE H63D 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>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-H63D-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:21.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942178</udiDi>
    <basicUdiDi>B-08437016942178</basicUdiDi>
    <tradeName>Genvinset® HFE H63D 24 tests</tradeName>
    <deviceName>Genvinset® HFE H63D 24 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>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-H63D-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:17.563Z</lastUpdated>
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    <udiDi>08437016942840</udiDi>
    <basicUdiDi>8437016942GVS-MTH-MRE</basicUdiDi>
    <tradeName>Genvinset® MTHFR multiplex 96 test</tradeName>
    <deviceName>Genvinset® MTHFR multiplex</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-MTH-M-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:33.100Z</lastUpdated>
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  <row>
    <udiDi>08437016942833</udiDi>
    <basicUdiDi>8437016942GVS-MTH-MRE</basicUdiDi>
    <tradeName>Genvinset® MTHFR multiplex 48 test</tradeName>
    <deviceName>Genvinset® MTHFR multiplex</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-MTH-M-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:26.840Z</lastUpdated>
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    <udiDi>08437016942826</udiDi>
    <basicUdiDi>8437016942GVS-MTH-MRE</basicUdiDi>
    <tradeName>Genvinset® MTHFR multiplex 24 test</tradeName>
    <deviceName>Genvinset® MTHFR multiplex</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-MTH-M-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:25.643Z</lastUpdated>
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  <row>
    <udiDi>08437016942819</udiDi>
    <basicUdiDi>8437016942GVS-HFEM3T</basicUdiDi>
    <tradeName>Genvinset® HFE multiplex 96 test</tradeName>
    <deviceName>Genvinset® HFE multiplex</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-HFE-M-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:24.450Z</lastUpdated>
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  <row>
    <udiDi>08437016942802</udiDi>
    <basicUdiDi>8437016942GVS-HFEM3T</basicUdiDi>
    <tradeName>Genvinset® HFE multiplex 48 test</tradeName>
    <deviceName>Genvinset® HFE multiplex</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-HFE-M-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:23.245Z</lastUpdated>
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  <row>
    <udiDi>08437016942796</udiDi>
    <basicUdiDi>8437016942GVS-HFEM3T</basicUdiDi>
    <tradeName>Genvinset® HFE multiplex 24 test</tradeName>
    <deviceName>Genvinset® HFE multiplex</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-HFE-M-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:17.242Z</lastUpdated>
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  <row>
    <udiDi>08437016942789</udiDi>
    <basicUdiDi>8437016942GVS-FIIFVPK</basicUdiDi>
    <tradeName>Genvinset® FIIFV multiplex 96 test</tradeName>
    <deviceName>Genvinset® FIIFV multiplex</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>W0103020299</emdnCode>
    <emdnDescription>COAGULATION FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FIIFV-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:16.041Z</lastUpdated>
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    <udiDi>08437016942772</udiDi>
    <basicUdiDi>8437016942GVS-FIIFVPK</basicUdiDi>
    <tradeName>Genvinset® FIIFV multiplex 48 test</tradeName>
    <deviceName>Genvinset® FIIFV multiplex</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>W0103020299</emdnCode>
    <emdnDescription>COAGULATION FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FIIFV-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:14.840Z</lastUpdated>
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    <udiDi>08437016942765</udiDi>
    <basicUdiDi>8437016942GVS-FIIFVPK</basicUdiDi>
    <tradeName>Genvinset® FIIFV multiplex 24 test</tradeName>
    <deviceName>Genvinset® FIIFV multiplex</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>W0103020299</emdnCode>
    <emdnDescription>COAGULATION FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FIIFV-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:13.643Z</lastUpdated>
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    <udiDi>08437016942758</udiDi>
    <basicUdiDi>8437016942GVS-S65CZR</basicUdiDi>
    <tradeName>Genvinset® HFE S65C 96 test</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-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:07.636Z</lastUpdated>
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    <udiDi>08437016942697</udiDi>
    <basicUdiDi>8437016942GVS-FIIQP</basicUdiDi>
    <tradeName>Genvinset® Factor II G20210A 96 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-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:06.431Z</lastUpdated>
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    <udiDi>08437016942666</udiDi>
    <basicUdiDi>8437016942GVS-B5CF</basicUdiDi>
    <tradeName>Genvinset® HLA Behçet v5 48 tests</tradeName>
    <deviceName>Genvinset® HLA Behçet v5</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-B505-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:05.232Z</lastUpdated>
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