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    <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>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:35.420Z</lastUpdated>
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    <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>
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    <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>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
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    <deviceName>FIBRINOGEN CLAUSS</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
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    <emdnDescription>COAGULATION FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:42:36.253Z</lastUpdated>
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    <tradeName>08435287100228</tradeName>
    <deviceName>FIBRINOGEN CLAUSS</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>COAGULATION FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:40:33.860Z</lastUpdated>
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    <deviceName>FIBRINOGEN CLAUSS</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>61002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:40:33.190Z</lastUpdated>
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    <tradeName>Thrombin-Antithrombin Complex Kit（CLIA）</tradeName>
    <deviceName>Thrombin-Antithrombin Complex Kit（CLIA）</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1414B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:58:23.311Z</lastUpdated>
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    <tradeName>Thrombin-Antithrombin Complex Kit（CLIA）</tradeName>
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    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <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>
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    <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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    <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>
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    <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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