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    <udiDi>08053172971922</udiDi>
    <basicUdiDi>B-08053172971922</basicUdiDi>
    <tradeName>D-Dimero</tradeName>
    <deviceName>D-Dimero/D-Dimer</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6737</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:47:37.437Z</lastUpdated>
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    <udiDi>06979878281382</udiDi>
    <basicUdiDi>B-06979878281382</basicUdiDi>
    <tradeName>06979878281382</tradeName>
    <deviceName>D-Dimer Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001032</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:17.619Z</lastUpdated>
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    <udiDi>06979469760395</udiDi>
    <basicUdiDi>B-06979469760395</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2403CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:24.512Z</lastUpdated>
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    <udiDi>06979469760388</udiDi>
    <basicUdiDi>B-06979469760388</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2404CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:20.511Z</lastUpdated>
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    <udiDi>06979469760371</udiDi>
    <basicUdiDi>B-06979469760371</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2402CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:19.710Z</lastUpdated>
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    <udiDi>06979469760364</udiDi>
    <basicUdiDi>B-06979469760364</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2402CL</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:18.912Z</lastUpdated>
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    <udiDi>06979355921060</udiDi>
    <basicUdiDi>B-06979355921060</basicUdiDi>
    <tradeName>06979355921060</tradeName>
    <deviceName>D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:15.286Z</lastUpdated>
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    <udiDi>06979355921053</udiDi>
    <basicUdiDi>B-06979355921053</basicUdiDi>
    <tradeName>06979355921053</tradeName>
    <deviceName>D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:14.487Z</lastUpdated>
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  <row>
    <udiDi>06979355921046</udiDi>
    <basicUdiDi>B-06979355921046</basicUdiDi>
    <tradeName>06979355921046</tradeName>
    <deviceName>D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:13.691Z</lastUpdated>
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  <row>
    <udiDi>06979355921039</udiDi>
    <basicUdiDi>B-06979355921039</basicUdiDi>
    <tradeName>06979355921039</tradeName>
    <deviceName>D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:09.682Z</lastUpdated>
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  <row>
    <udiDi>06979355921022</udiDi>
    <basicUdiDi>B-06979355921022</basicUdiDi>
    <tradeName>06979355921022</tradeName>
    <deviceName>D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:09.298Z</lastUpdated>
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    <udiDi>06979355921015</udiDi>
    <basicUdiDi>B-06979355921015</basicUdiDi>
    <tradeName>06979355921015</tradeName>
    <deviceName>D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:08.083Z</lastUpdated>
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  <row>
    <udiDi>06978945081658</udiDi>
    <basicUdiDi>B-06978945081658</basicUdiDi>
    <tradeName>Tissue Plasminogen Activator Inhibitor 1 Complex Kit（CLIA）</tradeName>
    <deviceName>Tissue Plasminogen Activator Inhibitor 1 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>
    <emdnCode>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1411B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:58:32.114Z</lastUpdated>
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    <udiDi>06978945081641</udiDi>
    <basicUdiDi>B-06978945081641</basicUdiDi>
    <tradeName>Tissue Plasminogen Activator Inhibitor 1 Complex Kit（CLIA）</tradeName>
    <deviceName>Tissue Plasminogen Activator Inhibitor 1 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>
    <emdnCode>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1411A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:58:30.508Z</lastUpdated>
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    <udiDi>06978945081412</udiDi>
    <basicUdiDi>B-06978945081412</basicUdiDi>
    <tradeName>D-Dimer Kit（CLIA）</tradeName>
    <deviceName>D-Dimer 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>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1408B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:57.682Z</lastUpdated>
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    <udiDi>06978945081405</udiDi>
    <basicUdiDi>B-06978945081405</basicUdiDi>
    <tradeName>D-Dimer Kit（CLIA）</tradeName>
    <deviceName>D-Dimer 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>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1408A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:56.237Z</lastUpdated>
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    <udiDi>06978945081399</udiDi>
    <basicUdiDi>B-06978945081399</basicUdiDi>
    <tradeName>Fibrinogen Degradation Product Kit（CLIA）</tradeName>
    <deviceName>Fibrinogen Degradation Product 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>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1409B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:52.076Z</lastUpdated>
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    <udiDi>06978945081382</udiDi>
    <basicUdiDi>B-06978945081382</basicUdiDi>
    <tradeName>Fibrinogen Degradation Product Kit（CLIA）</tradeName>
    <deviceName>Fibrinogen Degradation Product 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>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1409A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:51.423Z</lastUpdated>
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    <udiDi>06978189071514</udiDi>
    <basicUdiDi>B-06978189071514</basicUdiDi>
    <tradeName>06978189071514</tradeName>
    <deviceName>D-Dimer (DD) Test Kit</deviceName>
    <manufacturerName>Yantai JIEZI Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10tests/kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:42:10.108Z</lastUpdated>
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    <udiDi>06977565580541</udiDi>
    <basicUdiDi>B-06977565580541</basicUdiDi>
    <tradeName>D-Dimer Rapid Quantitative Test</tradeName>
    <deviceName>D-Dimer Rapid Quantitative Test</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0542</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:21:15.600Z</lastUpdated>
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