<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-HP149V7</udiDi>
    <basicUdiDi>B-HP149V7</basicUdiDi>
    <tradeName>HbA1c Control</tradeName>
    <deviceName>HbA1c Control</deviceName>
    <manufacturerName>Heavybio,Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000049958</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP149-3F, HP149-4F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:37.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HP106UM</udiDi>
    <basicUdiDi>B-HP106UM</basicUdiDi>
    <tradeName>CRP Control</tradeName>
    <deviceName>CRP Control</deviceName>
    <manufacturerName>Heavybio,Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000049958</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP106-1F,HP106-2F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:25.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HP103UF</udiDi>
    <basicUdiDi>B-HP103UF</basicUdiDi>
    <tradeName>PCT Control</tradeName>
    <deviceName>PCT Control</deviceName>
    <manufacturerName>Heavybio,Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000049958</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP103-2F, HP103-3F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:24.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HEVIgGCONZU</udiDi>
    <basicUdiDi>B-HEVIgGCONZU</basicUdiDi>
    <tradeName>HEV IgG (Liquid) Control</tradeName>
    <deviceName>HEV IgG (Liquid) Control</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEV IgG CON</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:54:11.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HAVIgMCONYS</udiDi>
    <basicUdiDi>B-HAVIgMCONYS</basicUdiDi>
    <tradeName>HAV IgM (Liquid) Control</tradeName>
    <deviceName>HAV IgM (Liquid) Control</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAV IgM CON</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:14.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HAVAbCONV9</udiDi>
    <basicUdiDi>B-HAVAbCONV9</basicUdiDi>
    <tradeName>HAV Ab (Liquid) Control</tradeName>
    <deviceName>HAV Ab (Liquid) Control</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAV Ab CON</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:13.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC278QZ</udiDi>
    <basicUdiDi>B-CC278QZ</basicUdiDi>
    <tradeName>HA Control</tradeName>
    <deviceName>HA Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC278</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:56:13.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI000013869</udiDi>
    <basicUdiDi>B-BI000013869</basicUdiDi>
    <tradeName>CRP Control 60 Blue</tradeName>
    <deviceName>CRP Control 60 Blue</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000138</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:26.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI00001345Z</udiDi>
    <basicUdiDi>B-BI00001345Z</basicUdiDi>
    <tradeName>CRP Control 140</tradeName>
    <deviceName>CRP Control 140</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000134</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:25.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI00001335X</udiDi>
    <basicUdiDi>B-BI00001335X</basicUdiDi>
    <tradeName>CRP Control 100</tradeName>
    <deviceName>CRP Control 100</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000133</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:21.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI00001325V</udiDi>
    <basicUdiDi>B-BI00001325V</basicUdiDi>
    <tradeName>CRP Control 60</tradeName>
    <deviceName>CRP Control 60</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000132</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:20.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI00001315T</udiDi>
    <basicUdiDi>B-BI00001315T</basicUdiDi>
    <tradeName>CRP Control 40</tradeName>
    <deviceName>CRP Control 40</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000131</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:20.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI00001305R</udiDi>
    <basicUdiDi>B-BI00001305R</basicUdiDi>
    <tradeName>CRP Control 25</tradeName>
    <deviceName>B-BI00001305R</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000130</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:19.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI000012968</udiDi>
    <basicUdiDi>B-BI000012968</basicUdiDi>
    <tradeName>CRP Control 15</tradeName>
    <deviceName>CRP Control 15</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000129</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:15.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI000012866</udiDi>
    <basicUdiDi>B-BI000012866</basicUdiDi>
    <tradeName>CRP Control POC</tradeName>
    <deviceName>CRP Control POC</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000128</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:14.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A24298UE</udiDi>
    <basicUdiDi>B-A24298UE</basicUdiDi>
    <tradeName>Access HBs Ab QC</tradeName>
    <deviceName>Access HBs Ab QC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A24298</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:53.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A24294U6</udiDi>
    <basicUdiDi>B-A24294U6</basicUdiDi>
    <tradeName>Access HBs Ag QC</tradeName>
    <deviceName>Access HBs Ag QC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A24294</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:43.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313277070</udiDi>
    <basicUdiDi>B-86060313277070</basicUdiDi>
    <tradeName>Hemoglobin/Haptoglobin Complex CONTROL MATERIAL</tradeName>
    <deviceName>Hemoglobin/Haptoglobin Complex CONTROL MATERIAL</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2035</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:15:26.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313276844</udiDi>
    <basicUdiDi>B-86060313276844</basicUdiDi>
    <tradeName>Anti-H. Pylori Control</tradeName>
    <deviceName>Anti-H. Pylori Control</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2037</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:15:25.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-474994S4</udiDi>
    <basicUdiDi>B-474994S4</basicUdiDi>
    <tradeName>SYNCHRON Systems ETOH Calibrator</tradeName>
    <deviceName>SYNCHRON Systems ETOH Calibrator</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>474994</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:04:58.732Z</lastUpdated>
  </row>
</eudamedExport>