<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-EBL22011017E</udiDi>
    <basicUdiDi>B-EBL22011017E</basicUdiDi>
    <tradeName>D-EBL22011017E</tradeName>
    <deviceName>Hematology Analyzer Fluorescent Platelets Control</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>W0103010505</emdnCode>
    <emdnDescription>PLATELET CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2201101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:40.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22011007C</udiDi>
    <basicUdiDi>B-EBL22011007C</basicUdiDi>
    <tradeName>D-EBL22011007C</tradeName>
    <deviceName>Hematology Analyzer Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2201100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:36.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22010047F</udiDi>
    <basicUdiDi>B-EBL22010047F</basicUdiDi>
    <tradeName>D-EBL22010047F</tradeName>
    <deviceName>Hematology Analyzer Control</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>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2201004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:35.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22010037D</udiDi>
    <basicUdiDi>B-EBL22010037D</basicUdiDi>
    <tradeName>D-EBL22010037D</tradeName>
    <deviceName>Hematology Analyzer Control</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>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2201003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:34.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22010027B</udiDi>
    <basicUdiDi>B-EBL22010027B</basicUdiDi>
    <tradeName>D-EBL22010027B</tradeName>
    <deviceName>Hematology Analyzer 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>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2201002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:33.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL220100179</udiDi>
    <basicUdiDi>B-EBL220100179</basicUdiDi>
    <tradeName>D-EBL220100179</tradeName>
    <deviceName>Hematology Analyzer 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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2201001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:29.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CW6792878P</udiDi>
    <basicUdiDi>B-CW6792878P</basicUdiDi>
    <tradeName>D-CW6792878P</tradeName>
    <deviceName>XN CHECK</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CW679287</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:39:22.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CU2486464X</udiDi>
    <basicUdiDi>B-CU2486464X</basicUdiDi>
    <tradeName>D-CU2486464X</tradeName>
    <deviceName>XN CHECK</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CU248646</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:38:50.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CT7029734B</udiDi>
    <basicUdiDi>B-CT7029734B</basicUdiDi>
    <tradeName>D-CT7029734B</tradeName>
    <deviceName>XN CHECK</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT702973</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:34:16.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CL552365XY</udiDi>
    <basicUdiDi>B-CL552365XY</basicUdiDi>
    <tradeName>D-CL552365XY</tradeName>
    <deviceName>e-CHECK(XS)</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL552365</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:07:03.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC211992RE</udiDi>
    <basicUdiDi>B-CC211992RE</basicUdiDi>
    <tradeName>D-CC211992RE</tradeName>
    <deviceName>XN-L CHECK</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC211992</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:56:08.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C07297V5</udiDi>
    <basicUdiDi>B-C07297V5</basicUdiDi>
    <tradeName>COULTER 6C Plus Cell Control</tradeName>
    <deviceName>COULTER 6C Plus Cell Control</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07297</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:50:28.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BS6605463P</udiDi>
    <basicUdiDi>B-BS6605463P</basicUdiDi>
    <tradeName>D-BS6605463P</tradeName>
    <deviceName>XN-L CHECK</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS660546</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:20.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BS4858985Q</udiDi>
    <basicUdiDi>B-BS4858985Q</basicUdiDi>
    <tradeName>D-BS4858985Q</tradeName>
    <deviceName>EIGHTCHECK-3WP</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS485898</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:19.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BP122483X3</udiDi>
    <basicUdiDi>B-BP122483X3</basicUdiDi>
    <tradeName>D-BP122483X3</tradeName>
    <deviceName>e-CHECK(XS)</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP122483</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:28:26.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-H2SR</udiDi>
    <basicUdiDi>B-BK-H2SR</basicUdiDi>
    <tradeName>BeneCheck Hb Hemoglobin Test Strip</tradeName>
    <deviceName>Hb Hemoglobin Test Strip</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-H2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:35.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-CSH329T</udiDi>
    <basicUdiDi>B-BK-CSH329T</basicUdiDi>
    <tradeName>BeneCheck Hb Hemoglobin Control Solution</tradeName>
    <deviceName>Hb hemoglobin control solution</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010606</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-CSH32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:22.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-CSH319R</udiDi>
    <basicUdiDi>B-BK-CSH319R</basicUdiDi>
    <tradeName>BeneCheck Hb Hemoglobin Control Solution</tradeName>
    <deviceName>Hb hemoglobin control solution</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010606</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-CSH31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:21.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-CSH309P</udiDi>
    <basicUdiDi>B-BK-CSH309P</basicUdiDi>
    <tradeName>BeneCheck Hb Hemoglobin Control Solution</tradeName>
    <deviceName>Hb hemoglobin control solution</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010606</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-CSH30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:21.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI00004236B</udiDi>
    <basicUdiDi>B-BI00004236B</basicUdiDi>
    <tradeName>B-Trol ESR Control L2</tradeName>
    <deviceName>B-Trol ESR Control L2</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000423</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:34.495Z</lastUpdated>
  </row>
</eudamedExport>