<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-4260152490173SQ</udiDi>
    <basicUdiDi>B-4260152490173SQ</basicUdiDi>
    <tradeName>Erytrocyten Kontrolle</tradeName>
    <deviceName>DP 350/ DP 550</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010606</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ERY QS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:45.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490166ST</udiDi>
    <basicUdiDi>B-4260152490166ST</basicUdiDi>
    <tradeName>Hämoglobin Kontrolle</tradeName>
    <deviceName>DP 350 / DP 550</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010606</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM QS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:44.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519631349</udiDi>
    <basicUdiDi>B-06975519631349</basicUdiDi>
    <tradeName>06975519631349</tradeName>
    <deviceName>Hemoglobin Control Solution</deviceName>
    <manufacturerName>Hangzhou Bosure Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003001</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010606</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA-231-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:33:13.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519630595</udiDi>
    <basicUdiDi>B-06975519630595</basicUdiDi>
    <tradeName>Hemoglobin Control Solution</tradeName>
    <deviceName>Hemoglobin Control Solution</deviceName>
    <manufacturerName>Hangzhou Bosure Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003001</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010606</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA-131-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:33:01.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339207050</udiDi>
    <basicUdiDi>B-06937339207050</basicUdiDi>
    <tradeName>Hemoglobin Testing System Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010606</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VOC02-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:54:37.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115001522</udiDi>
    <basicUdiDi>B-06438115001522</basicUdiDi>
    <tradeName>QuikRead go Hb 10 µl Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010606</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153656</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:08:03.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115000945</udiDi>
    <basicUdiDi>B-06438115000945</basicUdiDi>
    <tradeName>QuikRead go Hb Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010606</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>141154</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:07:31.798Z</lastUpdated>
  </row>
</eudamedExport>