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<eudamedExport entity="devices">
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    <basicUdiDi>B-0320515702WK</basicUdiDi>
    <tradeName>t-PAIC (eCLIA)</tradeName>
    <deviceName>t-PAIC (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320515702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:32:32.910Z</lastUpdated>
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    <udiDi>D-0320515701WH</udiDi>
    <basicUdiDi>B-0320515701WH</basicUdiDi>
    <tradeName>t-PAIC (eCLIA)</tradeName>
    <deviceName>t-PAIC (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320515701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:32:32.112Z</lastUpdated>
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    <udiDi>D-02B0019YW</udiDi>
    <basicUdiDi>B-02B0019YW</basicUdiDi>
    <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>
    <riskClass>IVD Genel</riskClass>
    <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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    <udiDi>06975984064222</udiDi>
    <basicUdiDi>69703416803205103J6</basicUdiDi>
    <tradeName>FDP (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>IVDR 2017/746</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:02.805Z</lastUpdated>
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    <udiDi>06975984064239</udiDi>
    <basicUdiDi>69703416803205103J6</basicUdiDi>
    <tradeName>FDP (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>IVDR 2017/746</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510203</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:02.718Z</lastUpdated>
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    <udiDi>06975984064246</udiDi>
    <basicUdiDi>69703416803205103J6</basicUdiDi>
    <tradeName>FDP (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>IVDR 2017/746</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:02.565Z</lastUpdated>
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    <udiDi>08426950078975</udiDi>
    <basicUdiDi>84269500789759B</basicUdiDi>
    <tradeName>HemosIL Plasminogen</tradeName>
    <deviceName>HemosIL Plasminogen</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020505</emdnCode>
    <emdnDescription>PLASMINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020009000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:56.258Z</lastUpdated>
  </row>
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    <udiDi>08426950031734</udiDi>
    <basicUdiDi>84269500317345N</basicUdiDi>
    <tradeName>HemosIL Plasmin Inhibitor</tradeName>
    <deviceName>HemosIL Plasmin Inhibitor</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020501</emdnCode>
    <emdnDescription>A2-ANTIPLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020009200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:05.758Z</lastUpdated>
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    <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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    <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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    <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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    <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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    <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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    <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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