<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-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-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-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>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>D-7M35FF</udiDi>
    <basicUdiDi>B-7M35FF</basicUdiDi>
    <tradeName>Thrombomodulin assay (CLIA)</tradeName>
    <deviceName>Thrombomodulin 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>W0103020399</emdnCode>
    <emdnDescription>SPECIAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M35V1-B-EU, 7M35U1-B-EU, 7M35P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:03.914Z</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>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>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>06975474516873</udiDi>
    <basicUdiDi>B-06975474516873</basicUdiDi>
    <tradeName>06975474516873</tradeName>
    <deviceName>Thrombelastograph Heparinase Cup Kit</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020303</emdnCode>
    <emdnDescription>STANDARD HEPARIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:33.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975474516866</udiDi>
    <basicUdiDi>B-06975474516866</basicUdiDi>
    <tradeName>06975474516866</tradeName>
    <deviceName>Thrombelastograph Heparinase Cup Kit</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020303</emdnCode>
    <emdnDescription>STANDARD HEPARIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:33.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975474516859</udiDi>
    <basicUdiDi>B-06975474516859</basicUdiDi>
    <tradeName>06975474516859</tradeName>
    <deviceName>Thrombelastograph Heparinase Cup Kit</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020303</emdnCode>
    <emdnDescription>STANDARD HEPARIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:32.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975474516842</udiDi>
    <basicUdiDi>B-06975474516842</basicUdiDi>
    <tradeName>06975474516842</tradeName>
    <deviceName>Thrombelastograph Heparinase Cup Kit</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020303</emdnCode>
    <emdnDescription>STANDARD HEPARIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 tests/kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:28.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975474516835</udiDi>
    <basicUdiDi>B-06975474516835</basicUdiDi>
    <tradeName>06975474516835</tradeName>
    <deviceName>Thrombelastograph Heparinase Cup Kit</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020303</emdnCode>
    <emdnDescription>STANDARD HEPARIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:27.439Z</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>06975070762155</udiDi>
    <basicUdiDi>B-06975070762155</basicUdiDi>
    <tradeName>Sharay TM (CLIA)</tradeName>
    <deviceName>Sharay TM (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>W0103020399</emdnCode>
    <emdnDescription>SPECIAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18303001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:37:25.502Z</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>
</eudamedExport>