<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06925912736264</udiDi>
    <basicUdiDi>692591270292HS</basicUdiDi>
    <tradeName>iFlash-TAT</tradeName>
    <deviceName>iFlash-TAT</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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:55.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768013065</udiDi>
    <basicUdiDi>0405686900931VT</basicUdiDi>
    <tradeName>Enzygnost TAT micro</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_Enz_TAT_mic</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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446632</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:38.440Z</lastUpdated>
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  <row>
    <udiDi>D-TAT706-AE6M</udiDi>
    <basicUdiDi>B-TAT706-AE6M</basicUdiDi>
    <tradeName>TAT Thrombin-Antithrombin III Complex (CLIA)</tradeName>
    <deviceName>TAT Thrombin-Antithrombin III 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TAT706-AE10Y, TAT706-AE10N, TAT706-AE20Y, TAT706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:47.244Z</lastUpdated>
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  <row>
    <udiDi>D-DC76109FJ</udiDi>
    <basicUdiDi>B-DC76109FJ</basicUdiDi>
    <tradeName>iStar-TAT</tradeName>
    <deviceName>iStar-TAT</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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76109</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:08.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76107FE</udiDi>
    <basicUdiDi>B-DC76107FE</basicUdiDi>
    <tradeName>iStar-TAT</tradeName>
    <deviceName>iStar-TAT</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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76107</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:06.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76108FG</udiDi>
    <basicUdiDi>B-DC76108FG</basicUdiDi>
    <tradeName>iStar-TAT</tradeName>
    <deviceName>iStar-TAT</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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76108</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:02.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76075FS</udiDi>
    <basicUdiDi>B-DC76075FS</basicUdiDi>
    <tradeName>iStar-TAT</tradeName>
    <deviceName>iStar-TAT</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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76075</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:04:15.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M37FK</udiDi>
    <basicUdiDi>B-7M37FK</basicUdiDi>
    <tradeName>Thrombin-Antithrombin III Complex assay (CLIA)</tradeName>
    <deviceName>Thrombin-Antithrombin III Complex 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M37V1-B-EU, 7M37U1-B-EU, 7M37P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:05.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912736325</udiDi>
    <basicUdiDi>692591270292HS</basicUdiDi>
    <tradeName>iFlash-TAT</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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86151-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:12.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172971830</udiDi>
    <basicUdiDi>B-08053172971830</basicUdiDi>
    <tradeName>Antitrombina III</tradeName>
    <deviceName>Antitrombina III/Anthithrombin III</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6704</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:47:28.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070762148</udiDi>
    <basicUdiDi>B-06975070762148</basicUdiDi>
    <tradeName>Sharay TAT (CLIA)</tradeName>
    <deviceName>Sharay TAT (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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18301001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:37:21.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893258</udiDi>
    <basicUdiDi>B-06974674893258</basicUdiDi>
    <tradeName>Thrombin-Antithrombin Complex(TAT) Detection Kit(CLIA)</tradeName>
    <deviceName>Thrombin-Antithrombin Complex(TAT) 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0197</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:48.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521004431</udiDi>
    <basicUdiDi>B-06974521004431</basicUdiDi>
    <tradeName>TAT Assay kit CLIA</tradeName>
    <deviceName>TAT 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM087072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:38:56.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521004424</udiDi>
    <basicUdiDi>B-06974521004424</basicUdiDi>
    <tradeName>TAT Assay kit CLIA</tradeName>
    <deviceName>TAT 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM087036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:38:55.208Z</lastUpdated>
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  <row>
    <udiDi>06972719604944</udiDi>
    <basicUdiDi>B-06972719604944</basicUdiDi>
    <tradeName>06972719604944</tradeName>
    <deviceName>Thrombin-Antithrombin III 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:48:12.684Z</lastUpdated>
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  <row>
    <udiDi>06972719604937</udiDi>
    <basicUdiDi>B-06972719604937</basicUdiDi>
    <tradeName>06972719604937</tradeName>
    <deviceName>Thrombin-Antithrombin III 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:48:08.660Z</lastUpdated>
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    <udiDi>06972719603091</udiDi>
    <basicUdiDi>B-06972719603091</basicUdiDi>
    <tradeName>06972719603091</tradeName>
    <deviceName>Thrombin-Antithrombin III 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:41:57.506Z</lastUpdated>
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  <row>
    <udiDi>06972719603084</udiDi>
    <basicUdiDi>B-06972719603084</basicUdiDi>
    <tradeName>06972719603084</tradeName>
    <deviceName>Thrombin-Antithrombin III 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:41:56.710Z</lastUpdated>
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  <row>
    <udiDi>06972719603077</udiDi>
    <basicUdiDi>B-06972719603077</basicUdiDi>
    <tradeName>06972719603077</tradeName>
    <deviceName>Thrombin-Antithrombin III 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:41:52.718Z</lastUpdated>
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    <udiDi>06972719601011</udiDi>
    <basicUdiDi>B-06972719601011</basicUdiDi>
    <tradeName>06972719601011</tradeName>
    <deviceName>Thrombin-Antithrombin III 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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215420001</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:34:01.685Z</lastUpdated>
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