<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987503610119</udiDi>
    <basicUdiDi>4987503A1MGUWK</basicUdiDi>
    <tradeName>α1-Microglobulin</tradeName>
    <deviceName>a1-Microglobulin</deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08944539190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:04:10.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987503610102</udiDi>
    <basicUdiDi>4987503A1MGUcal6J</basicUdiDi>
    <tradeName>α1-Microglobulin Calibrator Set</tradeName>
    <deviceName>α1-Microglobulin Calibrator Set</deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08944474190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:04:09.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987503563088</udiDi>
    <basicUdiDi>4987503sdLDLconPA</basicUdiDi>
    <tradeName>small dense LDL-Control Set</tradeName>
    <deviceName>small dense LDL-Control Set</deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08834105190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:04:08.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987503563071</udiDi>
    <basicUdiDi>4987503sdLDLcalMU</basicUdiDi>
    <tradeName>small dense LDL-Calibrator</tradeName>
    <deviceName>small dense LDL-Calibrator</deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08834091190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:04:07.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987503562883</udiDi>
    <basicUdiDi>4987503sdLDLNY</basicUdiDi>
    <tradeName>small dense LDL Seiken</tradeName>
    <deviceName>small dense LDL Seiken</deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08834059190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:04:06.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987503562890</udiDi>
    <basicUdiDi>4987503sdLDLNY</basicUdiDi>
    <tradeName>small dense LDL Seiken</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08834075190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:38.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987503562906</udiDi>
    <basicUdiDi>4987503sdLDLNY</basicUdiDi>
    <tradeName>small dense LDL Seiken</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08834083190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:38.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987503610126</udiDi>
    <basicUdiDi>4987503A1MGUWK</basicUdiDi>
    <tradeName>α1-Microglobulin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08944547190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:38.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987503610133</udiDi>
    <basicUdiDi>4987503A1MGUWK</basicUdiDi>
    <tradeName>α1-Microglobulin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08944555190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:38.441Z</lastUpdated>
  </row>
</eudamedExport>