<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-EBL22121007W</udiDi>
    <basicUdiDi>B-EBL22121007W</basicUdiDi>
    <tradeName>D-EBL22121007W</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>EBL2212100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:05.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22141008C</udiDi>
    <basicUdiDi>B-EBL22141008C</basicUdiDi>
    <tradeName>D-EBL22141008C</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>EBL2214100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:25:04.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22111017R</udiDi>
    <basicUdiDi>B-EBL22111017R</basicUdiDi>
    <tradeName>D-EBL22111017R</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>EBL2211101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:46.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22111007P</udiDi>
    <basicUdiDi>B-EBL22111007P</basicUdiDi>
    <tradeName>D-EBL22111007P</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>EBL2211100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:45.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22101017J</udiDi>
    <basicUdiDi>B-EBL22101017J</basicUdiDi>
    <tradeName>D-EBL22101017J</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>EBL2210101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:45.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22101007G</udiDi>
    <basicUdiDi>B-EBL22101007G</basicUdiDi>
    <tradeName>D-EBL22101007G</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>EBL2210100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:44.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL220910196</udiDi>
    <basicUdiDi>B-EBL220910196</basicUdiDi>
    <tradeName>D-EBL220910196</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>EBL2209101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:40.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL220910094</udiDi>
    <basicUdiDi>B-EBL220910094</basicUdiDi>
    <tradeName>D-EBL220910094</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>EBL2209100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:39.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL220900293</udiDi>
    <basicUdiDi>B-EBL220900293</basicUdiDi>
    <tradeName>D-EBL220900293</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>EBL2209002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:39.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22081018X</udiDi>
    <basicUdiDi>B-EBL22081018X</basicUdiDi>
    <tradeName>D-EBL22081018X</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>EBL2208101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:37.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22081008V</udiDi>
    <basicUdiDi>B-EBL22081008V</basicUdiDi>
    <tradeName>D-EBL22081008V</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>EBL2208100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:33.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22071018Q</udiDi>
    <basicUdiDi>B-EBL22071018Q</basicUdiDi>
    <tradeName>D-EBL22071018Q</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>EBL2207101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:33.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22071008N</udiDi>
    <basicUdiDi>B-EBL22071008N</basicUdiDi>
    <tradeName>D-EBL22071008N</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>EBL2207100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:32.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22061018H</udiDi>
    <basicUdiDi>B-EBL22061018H</basicUdiDi>
    <tradeName>D-EBL22061018H</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>EBL2206101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:31.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22061008F</udiDi>
    <basicUdiDi>B-EBL22061008F</basicUdiDi>
    <tradeName>D-EBL22061008F</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>EBL2206100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:27.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22060018C</udiDi>
    <basicUdiDi>B-EBL22060018C</basicUdiDi>
    <tradeName>D-EBL22060018C</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>EBL2206001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:26.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL22051018A</udiDi>
    <basicUdiDi>B-EBL22051018A</basicUdiDi>
    <tradeName>D-EBL22051018A</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>EBL2205101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:26.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL220510088</udiDi>
    <basicUdiDi>B-EBL220510088</basicUdiDi>
    <tradeName>D-EBL220510088</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>EBL2205100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:25.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL220500185</udiDi>
    <basicUdiDi>B-EBL220500185</basicUdiDi>
    <tradeName>D-EBL220500185</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>EBL2205001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:21.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL220410183</udiDi>
    <basicUdiDi>B-EBL220410183</basicUdiDi>
    <tradeName>D-EBL220410183</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>EBL2204101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:24:20.263Z</lastUpdated>
  </row>
</eudamedExport>