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<eudamedExport entity="devices">
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    <udiDi>06925912736271</udiDi>
    <basicUdiDi>692591270291HQ</basicUdiDi>
    <tradeName>iFlash-PIC</tradeName>
    <deviceName>iFlash-PIC</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86123</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:56.245Z</lastUpdated>
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  <row>
    <udiDi>D-PIC706-AEXD</udiDi>
    <basicUdiDi>B-PIC706-AEXD</basicUdiDi>
    <tradeName>PIC Plasmin-α2-Plasmin Inhibitor Complex (CLIA)</tradeName>
    <deviceName>PIC Plasmin-α2-Plasmin Inhibitor Complex (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIC706-AE10Y, PIC706-AE10N, PIC706-AE20Y, PIC706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:45:14.467Z</lastUpdated>
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  <row>
    <udiDi>D-DC76112F7</udiDi>
    <basicUdiDi>B-DC76112F7</basicUdiDi>
    <tradeName>iStar-PIC</tradeName>
    <deviceName>iStar-PIC</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76112</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:13.044Z</lastUpdated>
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  <row>
    <udiDi>D-DC76111F5</udiDi>
    <basicUdiDi>B-DC76111F5</basicUdiDi>
    <tradeName>iStar-PIC</tradeName>
    <deviceName>iStar-PIC</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:10.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76110F3</udiDi>
    <basicUdiDi>B-DC76110F3</basicUdiDi>
    <tradeName>iStar-PIC</tradeName>
    <deviceName>iStar-PIC</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76110</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:08.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76082FP</udiDi>
    <basicUdiDi>B-DC76082FP</basicUdiDi>
    <tradeName>iStar-PIC</tradeName>
    <deviceName>iStar-PIC</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76082</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:04:20.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M36FH</udiDi>
    <basicUdiDi>B-7M36FH</basicUdiDi>
    <tradeName>PIC assay (CLIA)</tradeName>
    <deviceName>PIC assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M36V1-B-EU, 7M36U1-B-EU, 7M36P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:04.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912736332</udiDi>
    <basicUdiDi>692591270291HQ</basicUdiDi>
    <tradeName>iFlash-PIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86123-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:12.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070762162</udiDi>
    <basicUdiDi>B-06975070762162</basicUdiDi>
    <tradeName>Sharay PIC (CLIA)</tradeName>
    <deviceName>Sharay PIC (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18302001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:37:26.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719604968</udiDi>
    <basicUdiDi>B-06972719604968</basicUdiDi>
    <tradeName>06972719604968</tradeName>
    <deviceName>Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:48:14.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719604951</udiDi>
    <basicUdiDi>B-06972719604951</basicUdiDi>
    <tradeName>06972719604951</tradeName>
    <deviceName>Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:48:13.464Z</lastUpdated>
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  <row>
    <udiDi>06972719603121</udiDi>
    <basicUdiDi>B-06972719603121</basicUdiDi>
    <tradeName>06972719603121</tradeName>
    <deviceName>Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:42:03.108Z</lastUpdated>
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  <row>
    <udiDi>06972719603114</udiDi>
    <basicUdiDi>B-06972719603114</basicUdiDi>
    <tradeName>06972719603114</tradeName>
    <deviceName>Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:42:01.511Z</lastUpdated>
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    <udiDi>06972719603107</udiDi>
    <basicUdiDi>B-06972719603107</basicUdiDi>
    <tradeName>06972719603107</tradeName>
    <deviceName>Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:41:59.108Z</lastUpdated>
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    <udiDi>06972719601028</udiDi>
    <basicUdiDi>B-06972719601028</basicUdiDi>
    <tradeName>06972719601028</tradeName>
    <deviceName>Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215430001</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:34:04.083Z</lastUpdated>
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  <row>
    <udiDi>D-0320515404W8</udiDi>
    <basicUdiDi>B-0320515404W8</basicUdiDi>
    <tradeName>PIC (eCLIA)</tradeName>
    <deviceName>PIC (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>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320515404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:32:17.697Z</lastUpdated>
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  <row>
    <udiDi>D-0320515403W6</udiDi>
    <basicUdiDi>B-0320515403W6</basicUdiDi>
    <tradeName>PIC (eCLIA)</tradeName>
    <deviceName>PIC (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>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W0103020305</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:32:15.296Z</lastUpdated>
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  <row>
    <udiDi>D-0320515402W4</udiDi>
    <basicUdiDi>B-0320515402W4</basicUdiDi>
    <tradeName>PIC (eCLIA)</tradeName>
    <deviceName>PIC (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>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320515402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:32:13.698Z</lastUpdated>
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    <udiDi>D-0320515401W2</udiDi>
    <basicUdiDi>B-0320515401W2</basicUdiDi>
    <tradeName>PIC (eCLIA)</tradeName>
    <deviceName>PIC (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>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320515401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:32:12.890Z</lastUpdated>
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  <row>
    <udiDi>06954414798739</udiDi>
    <basicUdiDi>B-06954414798739</basicUdiDi>
    <tradeName>MAGICL PIC (CLIA)</tradeName>
    <deviceName>MAGICL PIC (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:34:26.525Z</lastUpdated>
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