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    <tradeName>SALSA MLPA Probemix P008 PMS2</tradeName>
    <deviceName>SALSA MLPA Probemix P008 PMS2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</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>P008-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:44.204Z</lastUpdated>
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    <udiDi>08720211480232</udiDi>
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    <tradeName>SALSA MLPA Probemix P008 PMS2</tradeName>
    <deviceName>SALSA MLPA Probemix P008 PMS2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:43.001Z</lastUpdated>
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    <udiDi>08720211480225</udiDi>
    <basicUdiDi>872021148P0085L</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P008 PMS2</tradeName>
    <deviceName>SALSA MLPA Probemix P008 PMS2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:41.800Z</lastUpdated>
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    <udiDi>08720211480041</udiDi>
    <basicUdiDi>872021148P00258</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P002 BRCA1</tradeName>
    <deviceName>SALSA MLPA Probemix P002 BRCA1</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</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>P002-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:40.601Z</lastUpdated>
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    <udiDi>08720211480034</udiDi>
    <basicUdiDi>872021148P00258</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P002 BRCA1</tradeName>
    <deviceName>SALSA MLPA Probemix P002 BRCA1</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</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>P002-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:34.597Z</lastUpdated>
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    <udiDi>08720211480010</udiDi>
    <basicUdiDi>872021148P00258</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P002 BRCA1</tradeName>
    <deviceName>SALSA MLPA Probemix P002 BRCA1</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</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>P002-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:42:33.417Z</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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    <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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    <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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    <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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    <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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    <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>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>
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    <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>
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    <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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    <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>
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    <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>
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    <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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    <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>
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    <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>
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