<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-EBL21810069W</udiDi>
    <basicUdiDi>B-EBL21810069W</basicUdiDi>
    <tradeName>D-EBL21810069W</tradeName>
    <deviceName>Fibrinogen Degradation Product (FDP) Calibrator</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2181006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:08.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21140027W</udiDi>
    <basicUdiDi>B-EBL21140027W</basicUdiDi>
    <tradeName>D-EBL21140027W</tradeName>
    <deviceName>Prothrombin Time (PT)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2114002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:04.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21130047T</udiDi>
    <basicUdiDi>B-EBL21130047T</basicUdiDi>
    <tradeName>D-EBL21130047T</tradeName>
    <deviceName>Fibrinogen (Fib)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2113004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:03.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21810059U</udiDi>
    <basicUdiDi>B-EBL21810059U</basicUdiDi>
    <tradeName>D-EBL21810059U</tradeName>
    <deviceName>D-Dimer Calibrator</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2181005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:02.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL211500285</udiDi>
    <basicUdiDi>B-EBL211500285</basicUdiDi>
    <tradeName>D-EBL211500285</tradeName>
    <deviceName>Prothrombin Time (PT)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2115002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:01.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21130037R</udiDi>
    <basicUdiDi>B-EBL21130037R</basicUdiDi>
    <tradeName>D-EBL21130037R</tradeName>
    <deviceName>Thrombin Time (TT)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2113003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:45.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21130027P</udiDi>
    <basicUdiDi>B-EBL21130027P</basicUdiDi>
    <tradeName>D-EBL21130027P</tradeName>
    <deviceName>Prothrombin Time (PT)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2113002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:44.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21120047L</udiDi>
    <basicUdiDi>B-EBL21120047L</basicUdiDi>
    <tradeName>D-EBL21120047L</tradeName>
    <deviceName>Fibrinogen (Fib)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2112004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:43.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21120037J</udiDi>
    <basicUdiDi>B-EBL21120037J</basicUdiDi>
    <tradeName>D-EBL21120037J</tradeName>
    <deviceName>Thrombin Time (TT)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2112003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:42.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21120027G</udiDi>
    <basicUdiDi>B-EBL21120027G</basicUdiDi>
    <tradeName>D-EBL21120027G</tradeName>
    <deviceName>Prothrombin Time (PT)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2112002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:38.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21120017E</udiDi>
    <basicUdiDi>B-EBL21120017E</basicUdiDi>
    <tradeName>D-EBL21120017E</tradeName>
    <deviceName>APTT</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2112001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:37.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21110047D</udiDi>
    <basicUdiDi>B-EBL21110047D</basicUdiDi>
    <tradeName>D-EBL21110047D</tradeName>
    <deviceName>Fibrinogen (Fib)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2111004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:36.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21110037B</udiDi>
    <basicUdiDi>B-EBL21110037B</basicUdiDi>
    <tradeName>D-EBL21110037B</tradeName>
    <deviceName>Thrombin Time (TT)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2111003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:36.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL211100279</udiDi>
    <basicUdiDi>B-EBL211100279</basicUdiDi>
    <tradeName>D-EBL211100279</tradeName>
    <deviceName>Prothrombin Time (PT)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2111002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:32.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL211100177</udiDi>
    <basicUdiDi>B-EBL211100177</basicUdiDi>
    <tradeName>D-EBL211100177</tradeName>
    <deviceName>APTT</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2111001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:31.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL211000476</udiDi>
    <basicUdiDi>B-EBL211000476</basicUdiDi>
    <tradeName>D-EBL211000476</tradeName>
    <deviceName>Fibrinogen (Fib)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2110004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:30.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL211000374</udiDi>
    <basicUdiDi>B-EBL211000374</basicUdiDi>
    <tradeName>D-EBL211000374</tradeName>
    <deviceName>Thrombin Time (TT)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2110003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:29.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21100016Y</udiDi>
    <basicUdiDi>B-EBL21100016Y</basicUdiDi>
    <tradeName>D-EBL21100016Y</tradeName>
    <deviceName>APTT</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2110001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:25.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21070088L</udiDi>
    <basicUdiDi>B-EBL21070088L</basicUdiDi>
    <tradeName>D-EBL21070088L</tradeName>
    <deviceName>D-Dimer</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2107008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:24.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21070078J</udiDi>
    <basicUdiDi>B-EBL21070078J</basicUdiDi>
    <tradeName>D-EBL21070078J</tradeName>
    <deviceName>Fibrinogen Degradation Product (FDP)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020502</emdnCode>
    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2107007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:24.106Z</lastUpdated>
  </row>
</eudamedExport>