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    <deviceName>Genvinset® HFE S65C</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
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    <deviceName>Genvinset® HFE S65C</deviceName>
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    <tradeName>A1AT Genotyping Test Reagents</tradeName>
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    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
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    <tradeName>A1AT Genotyping Test Reagents</tradeName>
    <deviceName>A1AT Genotyping Test</deviceName>
    <manufacturerName>Progenika Biopharma, S.A.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <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>
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    <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>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010116</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-THP-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:05.157Z</lastUpdated>
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    <tradeName>Genvinset® Thrombo panel 24 test</tradeName>
    <deviceName>Genvinset® Thrombo panel</deviceName>
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    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-THP-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:03.990Z</lastUpdated>
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    <tradeName>Genvinset® PAI-1/FXIII multiplex 96 test</tradeName>
    <deviceName>Genvinset® PAI-1/FXIII multiplex</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-PAI/F13-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:02.776Z</lastUpdated>
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    <tradeName>Genvinset® PAI-1/FXIII multiplex 48 test</tradeName>
    <deviceName>Genvinset® PAI-1/FXIII multiplex</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>W0106010116</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-PAI/F13-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:34:01.685Z</lastUpdated>
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    <tradeName>Genvinset® PAI-1/FXIII multiplex 24 test</tradeName>
    <deviceName>Genvinset® PAI-1/FXIII multiplex</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-PAI/F13-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:33:54.355Z</lastUpdated>
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    <tradeName>Duplicα RealTime Mix &amp; Match Factor V G1691A Kit QS</tradeName>
    <deviceName>Duplica Real Time Mix &amp; Match FACTOR V G1691A Kit</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EER038032QS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:45.099Z</lastUpdated>
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    <tradeName>Duplica Real Time Mix &amp; Match FACTOR V G1691A Kit</tradeName>
    <deviceName>Duplica Real Time Mix &amp; Match FACTOR V G1691A Kit</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
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    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
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    <reference>EER038032</reference>
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    <lastUpdated>2026-06-30T12:11:43.900Z</lastUpdated>
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    <tradeName>Eu-Gen FII/FV Type (25 T)</tradeName>
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    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
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    <emdnCode>W0106010115</emdnCode>
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    <reference>9462S</reference>
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    <tradeName>Devyser Thalassemia v2</tradeName>
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    <lastUpdated>2026-06-30T09:48:24.312Z</lastUpdated>
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    <tradeName>ß-THALASSAEMIA &amp; HbA1c Reagent Kit (HPLC)</tradeName>
    <deviceName>ß-THALASSAEMIA &amp; HbA1c Reagent Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <tradeName>ThromboGUARD FII FV</tradeName>
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    <manufacturerName>APPOLON BIOTECK</manufacturerName>
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