<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08437016942925</udiDi>
    <basicUdiDi>B-08437016942925</basicUdiDi>
    <tradeName>Genvinset® HLA DQA1*05 48 test</tradeName>
    <deviceName>Genvinset® HLA DQA1*05 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>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DQA5-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:42.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942918</udiDi>
    <basicUdiDi>B-08437016942918</basicUdiDi>
    <tradeName>Genvinset® HLA DQA1*05 24 tests</tradeName>
    <deviceName>Genvinset® HLA DQA1*05 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>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DQA5-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:41.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942901</udiDi>
    <basicUdiDi>B-08437016942901</basicUdiDi>
    <tradeName>Genvinset® deltaF508 96 tests</tradeName>
    <deviceName>Genvinset® deltaF508 96 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>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DF508-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:40.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942895</udiDi>
    <basicUdiDi>B-08437016942895</basicUdiDi>
    <tradeName>Genvinset® deltaF508 48 tests</tradeName>
    <deviceName>Genvinset® deltaF508 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>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DF508-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:39.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942888</udiDi>
    <basicUdiDi>B-08437016942888</basicUdiDi>
    <tradeName>Genvinset® deltaF508 24 tests</tradeName>
    <deviceName>Genvinset® deltaF508 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>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DF508-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:35.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942857</udiDi>
    <basicUdiDi>B-08437016942857</basicUdiDi>
    <tradeName>Genvinset® PAI-1 4G/5G 96 tests</tradeName>
    <deviceName>Genvinset® PAI-1 4G/5G 96 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>W0103020299</emdnCode>
    <emdnDescription>COAGULATION FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-PAI-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:35.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942741</udiDi>
    <basicUdiDi>B-08437016942741</basicUdiDi>
    <tradeName>Genvinset® HFE C282Y 96 tests</tradeName>
    <deviceName>Genvinset® HFE C282Y 96 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-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:34.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942734</udiDi>
    <basicUdiDi>B-08437016942734</basicUdiDi>
    <tradeName>Genvinset® HFE H63D 96 tests</tradeName>
    <deviceName>Genvinset® HFE H63D 96 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-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:32.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942727</udiDi>
    <basicUdiDi>B-08437016942727</basicUdiDi>
    <tradeName>Genvinset® MTHFR A1298C 96 tests</tradeName>
    <deviceName>Genvinset® MTHFR A1298C 96 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-A1298C-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:28.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942710</udiDi>
    <basicUdiDi>B-08437016942710</basicUdiDi>
    <tradeName>Genvinset®  MTHFR C677T 96 tests</tradeName>
    <deviceName>Genvinset® MTHFR C677T 96 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-MTHFR-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:27.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942703</udiDi>
    <basicUdiDi>B-08437016942703</basicUdiDi>
    <tradeName>Genvinset® Factor V G1691A 96 tests</tradeName>
    <deviceName>Genvinset® Factor V G1691A 96 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-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:27.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942680</udiDi>
    <basicUdiDi>B-08437016942680</basicUdiDi>
    <tradeName>Genvinset® HLA B57v5 48 tests</tradeName>
    <deviceName>Genvinset® HLA B57v5 48 tests</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</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>GVS-B5705-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:26.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942673</udiDi>
    <basicUdiDi>B-08437016942673</basicUdiDi>
    <tradeName>Genvinset® HLA B57v5 24 tests</tradeName>
    <deviceName>Genvinset® HLA B57v5 24 tests</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</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>GVS-B5705-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:21.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942598</udiDi>
    <basicUdiDi>B-08437016942598</basicUdiDi>
    <tradeName>Genvinset® PAI-1 4G/5G 48 tests</tradeName>
    <deviceName>Genvinset® PAI-1 4G/5G 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>W0103020299</emdnCode>
    <emdnDescription>COAGULATION FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-PAI-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:20.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942581</udiDi>
    <basicUdiDi>B-08437016942581</basicUdiDi>
    <tradeName>Genvinset® PAI-1 4G/5G 24 tests</tradeName>
    <deviceName>Genvinset® PAI-1 4G/5G 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>W0103020299</emdnCode>
    <emdnDescription>COAGULATION FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-PAI-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:19.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942574</udiDi>
    <basicUdiDi>B-08437016942574</basicUdiDi>
    <tradeName>Genvinset® MTHFR A1298C 48 tests</tradeName>
    <deviceName>Genvinset® MTHFR A1298C 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-A1298C-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:19.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942567</udiDi>
    <basicUdiDi>B-08437016942567</basicUdiDi>
    <tradeName>Genvinset® MTHFR A1298C 24 tests</tradeName>
    <deviceName>Genvinset® MTHFR A1298C 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-A1298C-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:35.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942406</udiDi>
    <basicUdiDi>B-08437016942406</basicUdiDi>
    <tradeName>Genvinset® MTHFR C677T 48 tests</tradeName>
    <deviceName>Genvinset® MTHFR C677T 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-MTHFR-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:34.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942390</udiDi>
    <basicUdiDi>B-08437016942390</basicUdiDi>
    <tradeName>Genvinset® MTHFR C677T 24 tests</tradeName>
    <deviceName>Genvinset® MTHFR C677T 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-MTHFR-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:33.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942383</udiDi>
    <basicUdiDi>B-08437016942383</basicUdiDi>
    <tradeName>Genvinset® Factor V G1691A 48 tests</tradeName>
    <deviceName>Genvinset® Factor V G1691A 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>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FV-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:30.375Z</lastUpdated>
  </row>
</eudamedExport>