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    <tradeName>D-02B0019YW</tradeName>
    <deviceName>D-Dimer Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2N001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:11.859Z</lastUpdated>
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    <udiDi>08436003070733</udiDi>
    <basicUdiDi>8436003070726XV</basicUdiDi>
    <tradeName>D-Dimer Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R1001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T22:38:50.167Z</lastUpdated>
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    <udiDi>08436003070740</udiDi>
    <basicUdiDi>8436003070726XV</basicUdiDi>
    <tradeName>D-Dimer Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R1010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T22:38:50.141Z</lastUpdated>
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    <udiDi>D-000012807163080PS</udiDi>
    <basicUdiDi>B-000012807163080PS</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>D-Dimer Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</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>HWTS-OT101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:48.372Z</lastUpdated>
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  <row>
    <udiDi>06970341688042</udiDi>
    <basicUdiDi>69703416803205040J7</basicUdiDi>
    <tradeName>D-Dimer STAT (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320500301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:05.489Z</lastUpdated>
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    <udiDi>06975984063034</udiDi>
    <basicUdiDi>69703416803205040J7</basicUdiDi>
    <tradeName>D-Dimer STAT (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320500304</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:05.212Z</lastUpdated>
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  <row>
    <udiDi>27350060320189</udiDi>
    <basicUdiDi>7350060320106M</basicUdiDi>
    <tradeName>MRX Green D-dimer</tradeName>
    <deviceName>Green D-dimer</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5011</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:02:19.231Z</lastUpdated>
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  <row>
    <udiDi>27350060320172</udiDi>
    <basicUdiDi>73500603200974</basicUdiDi>
    <tradeName>MRX Blue D-dimer</tradeName>
    <deviceName>Blue D-dimer</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5035</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:02:18.430Z</lastUpdated>
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    <udiDi>27350060320066</udiDi>
    <basicUdiDi>7350060320026N</basicUdiDi>
    <tradeName>MRX Red D-dimer</tradeName>
    <deviceName>Red D-dimer</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5034</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:02:12.047Z</lastUpdated>
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  <row>
    <udiDi>06975182500164</udiDi>
    <basicUdiDi>697518250P160016F</basicUdiDi>
    <tradeName>D-Dimer Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>D-Dimer Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P16001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:19:47.532Z</lastUpdated>
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  <row>
    <udiDi>06939716400153</udiDi>
    <basicUdiDi>693971640714M5</basicUdiDi>
    <tradeName>HOKAPI™ D-DIMER</tradeName>
    <deviceName>HOKAPI™ D-DIMER</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010714101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:23:34.944Z</lastUpdated>
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  <row>
    <udiDi>16438153000744</udiDi>
    <basicUdiDi>6438153BU00062BP</basicUdiDi>
    <tradeName>D-Dimer</tradeName>
    <deviceName>D-Dimer</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981946</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:05:07.166Z</lastUpdated>
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  <row>
    <udiDi>03573026620899</udiDi>
    <basicUdiDi>357302BUDI000197TQ</basicUdiDi>
    <tradeName>VIDAS® D-Dimer Exclusion II™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30455-30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:35:35.179Z</lastUpdated>
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  <row>
    <udiDi>05204309086948</udiDi>
    <basicUdiDi>5204309000020NG</basicUdiDi>
    <tradeName>D-DIMER</tradeName>
    <deviceName>D-DIMER</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1418-1180</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:53:13.982Z</lastUpdated>
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    <udiDi>04260743470478</udiDi>
    <basicUdiDi>426074347.2.13.1.500.4N</basicUdiDi>
    <tradeName>VELLAP D-Dimer</tradeName>
    <deviceName>VELLAP D-Dimer</deviceName>
    <manufacturerName>VELLAP Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.13.6.2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:08:59.703Z</lastUpdated>
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    <udiDi>00630414627908</udiDi>
    <basicUdiDi>0405686900174V5</basicUdiDi>
    <tradeName>INNOVANCE D-Dimer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873786</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:45:45.095Z</lastUpdated>
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    <udiDi>08426950554035</udiDi>
    <basicUdiDi>84269505540357Z</basicUdiDi>
    <tradeName>HemosIL D-Dimer 500</tradeName>
    <deviceName>HemosIL D-Dimer 500</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020301000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:24:47.992Z</lastUpdated>
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    <udiDi>08426950496946</udiDi>
    <basicUdiDi>8426950496946AY</basicUdiDi>
    <tradeName>HemosIL AcuStar D-Dimer</tradeName>
    <deviceName>HemosIL AcuStar D-Dimer</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:24:26.382Z</lastUpdated>
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    <udiDi>08426950485605</udiDi>
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    <tradeName>HemosIL D-Dimer HS 500</tradeName>
    <deviceName>HemosIL D-Dimer HS 500</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020500100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:24:22.895Z</lastUpdated>
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    <tradeName>HemosIL D-Dimer HS</tradeName>
    <deviceName>HemosIL D-Dimer HS</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020007700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:23:33.561Z</lastUpdated>
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