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    <tradeName>D-Dimer Rapid Test</tradeName>
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    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
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    <tradeName>D-dimer Test Kit (Homogeneous Chemiluminescence Immunoassay)</tradeName>
    <deviceName>D-dimer Test Kit (Homogeneous Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Nanjing Poclight Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039609</manufacturerSrn>
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    <tradeName>tPAIC Assay kit CLIA</tradeName>
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    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
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    <tradeName>tPAIC Assay kit CLIA</tradeName>
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    <tradeName>PIC Assay kit CLIA</tradeName>
    <deviceName>PIC Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
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    <tradeName>PIC Assay kit CLIA</tradeName>
    <deviceName>PIC Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
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    <tradeName>FDP Assay kit CLIA</tradeName>
    <deviceName>FDP Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
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    <tradeName>FDP Assay kit CLIA</tradeName>
    <deviceName>FDP Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
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    <tradeName>D-Dimer Assay Kit CLIA</tradeName>
    <deviceName>D-Dimer Assay Kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM037072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:19.314Z</lastUpdated>
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    <basicUdiDi>B-06974521001430</basicUdiDi>
    <tradeName>D-Dimer Assay Kit CLIA</tradeName>
    <deviceName>D-Dimer Assay Kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM037036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:18.548Z</lastUpdated>
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    <udiDi>06974521000570</udiDi>
    <basicUdiDi>B-06974521000570</basicUdiDi>
    <tradeName>Diagnostic Kit for D-Dimer (DD) (Time-resolved Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Diagnostic Kit for D-Dimer(DD) (Time-resolved Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPF015025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:27:21.454Z</lastUpdated>
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    <basicUdiDi>B-06974473308557</basicUdiDi>
    <tradeName>D-Dimer Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>D-Dimer Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XJ002</reference>
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    <lastUpdated>2026-07-06T16:12:12.787Z</lastUpdated>
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    <basicUdiDi>B-06974473300070</basicUdiDi>
    <tradeName>D-Dimer Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</tradeName>
    <deviceName>D-Dimer Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>D-DIMER</emdnDescription>
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    <lastUpdated>2026-07-06T16:09:54.215Z</lastUpdated>
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    <basicUdiDi>B-06974464591418</basicUdiDi>
    <tradeName>D-Dimer (DD) Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>D-Dimer (DD) Rapid Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Guangzhou Decheng Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013536</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <reference>5274C4X025</reference>
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    <tradeName>06974323014249</tradeName>
    <deviceName>D-Dimer rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
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    <deviceName>D-Dimer rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
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    <deviceName>D-Dimer rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
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    <deviceName>Fibrinogen/Fibrin Degradation Products (PDF) rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
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    <deviceName>Fibrinogen/Fibrin Degradation Products (PDF) rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
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    <deviceName>Fibrinogen/Fibrin Degradation Products (PDF) rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
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