<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974738205126</udiDi>
    <basicUdiDi>B-06974738205126</basicUdiDi>
    <tradeName>D-Dimer Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</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>IF14-01-40</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:38:05.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974738205119</udiDi>
    <basicUdiDi>B-06974738205119</basicUdiDi>
    <tradeName>D-Dimer Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</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>IF14-01-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:38:03.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893296</udiDi>
    <basicUdiDi>B-06974674893296</basicUdiDi>
    <tradeName>Fibrin/Fibrinogen Degradation Products(FDP) Detection Kit(CLIA)</tradeName>
    <deviceName>Fibrin/Fibrinogen Degradation Products(FDP) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:58.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893289</udiDi>
    <basicUdiDi>B-06974674893289</basicUdiDi>
    <tradeName>Tissue plasminogen activator-Plasminogen activator inhibitor Complex(t-PAIC) Detection Kit(CLIA)</tradeName>
    <deviceName>Tissue plasminogen activator-Plasminogen activator inhibitor Complex(t-PAIC) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:56.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893265</udiDi>
    <basicUdiDi>B-06974674893265</basicUdiDi>
    <tradeName>α2-plasmininhibitor-Plasmin Complex(PIC) Detection Kit(CLIA)</tradeName>
    <deviceName>α2-plasmininhibitor-Plasmin Complex(PIC) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020504</emdnCode>
    <emdnDescription>PLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0198</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:54.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892701</udiDi>
    <basicUdiDi>B-06974674892701</basicUdiDi>
    <tradeName>D-Dimer Detection Kit(CLIA)</tradeName>
    <deviceName>D-Dimer Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0142</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:53.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671101875</udiDi>
    <basicUdiDi>B-06974671101875</basicUdiDi>
    <tradeName>06974671101875</tradeName>
    <deviceName>D-Dimer Quantitative Diagnostic Kit (CLIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CLIA-CK-A039</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:10:11.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566303513</udiDi>
    <basicUdiDi>B-06974566303513</basicUdiDi>
    <tradeName>D-Dimer Rapid Test</tradeName>
    <deviceName>D-Dimer Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDD-402</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:07.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566303506</udiDi>
    <basicUdiDi>B-06974566303506</basicUdiDi>
    <tradeName>D-Dimer Rapid Test</tradeName>
    <deviceName>D-Dimer Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDD-40225</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:07.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974524061608</udiDi>
    <basicUdiDi>B-06974524061608</basicUdiDi>
    <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>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCLIA15124</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:49:12.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521004493</udiDi>
    <basicUdiDi>B-06974521004493</basicUdiDi>
    <tradeName>tPAIC Assay kit CLIA</tradeName>
    <deviceName>tPAIC Assay kit CLIA</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>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM085072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:39:07.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521004486</udiDi>
    <basicUdiDi>B-06974521004486</basicUdiDi>
    <tradeName>tPAIC Assay kit CLIA</tradeName>
    <deviceName>tPAIC Assay kit CLIA</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>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM085036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:39:03.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521004318</udiDi>
    <basicUdiDi>B-06974521004318</basicUdiDi>
    <tradeName>PIC Assay kit CLIA</tradeName>
    <deviceName>PIC Assay kit CLIA</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>W0103020504</emdnCode>
    <emdnDescription>PLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM086072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:38:23.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521004301</udiDi>
    <basicUdiDi>B-06974521004301</basicUdiDi>
    <tradeName>PIC Assay kit CLIA</tradeName>
    <deviceName>PIC Assay kit CLIA</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>W0103020504</emdnCode>
    <emdnDescription>PLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM086036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:38:22.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521004097</udiDi>
    <basicUdiDi>B-06974521004097</basicUdiDi>
    <tradeName>FDP Assay kit CLIA</tradeName>
    <deviceName>FDP Assay kit CLIA</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM084072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:37:51.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521004080</udiDi>
    <basicUdiDi>B-06974521004080</basicUdiDi>
    <tradeName>FDP Assay kit CLIA</tradeName>
    <deviceName>FDP Assay kit CLIA</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>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM084036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:37:48.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521001447</udiDi>
    <basicUdiDi>B-06974521001447</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>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM037072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:19.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521001430</udiDi>
    <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>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM037036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:18.548Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>06974473308557</udiDi>
    <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>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XJ002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:12:12.787Z</lastUpdated>
  </row>
</eudamedExport>