<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-EIM4492115JK</udiDi>
    <basicUdiDi>B-EIM4492115JK</basicUdiDi>
    <tradeName>D-EIM4492115JK</tradeName>
    <deviceName>HE4 Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4492115</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:53.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4492114JH</udiDi>
    <basicUdiDi>B-EIM4492114JH</basicUdiDi>
    <tradeName>D-EIM4492114JH</tradeName>
    <deviceName>CA 242 Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4492114</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:52.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4492113JF</udiDi>
    <basicUdiDi>B-EIM4492113JF</basicUdiDi>
    <tradeName>D-EIM4492113JF</tradeName>
    <deviceName>CA72-4 Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4492113</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:48.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4491115JC</udiDi>
    <basicUdiDi>B-EIM4491115JC</basicUdiDi>
    <tradeName>D-EIM4491115JC</tradeName>
    <deviceName>HE4 Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4491115</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:45.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4491114JA</udiDi>
    <basicUdiDi>B-EIM4491114JA</basicUdiDi>
    <tradeName>D-EIM4491114JA</tradeName>
    <deviceName>CA 242 Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4491114</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:41.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4491113J8</udiDi>
    <basicUdiDi>B-EIM4491113J8</basicUdiDi>
    <tradeName>D-EIM4491113J8</tradeName>
    <deviceName>CA72-4 Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4491113</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:40.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4299106K9</udiDi>
    <basicUdiDi>B-EIM4299106K9</basicUdiDi>
    <tradeName>D-EIM4299106K9</tradeName>
    <deviceName>Chemiluminescent Immunoassay Controls for Tumor Marker 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4299106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:57:24.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4298507KQ</udiDi>
    <basicUdiDi>B-EIM4298507KQ</basicUdiDi>
    <tradeName>D-EIM4298507KQ</tradeName>
    <deviceName>Maternal 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4298507</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:57:22.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4298505KL</udiDi>
    <basicUdiDi>B-EIM4298505KL</basicUdiDi>
    <tradeName>D-EIM4298505KL</tradeName>
    <deviceName>Insulin &amp; C-Peptide 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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4298505</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:57:20.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4298112JV</udiDi>
    <basicUdiDi>B-EIM4298112JV</basicUdiDi>
    <tradeName>D-EIM4298112JV</tradeName>
    <deviceName>CA50 Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4298112</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:57:16.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4298111JT</udiDi>
    <basicUdiDi>B-EIM4298111JT</basicUdiDi>
    <tradeName>D-EIM4298111JT</tradeName>
    <deviceName>SCC Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4298111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:57:14.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4298109K8</udiDi>
    <basicUdiDi>B-EIM4298109K8</basicUdiDi>
    <tradeName>D-EIM4298109K8</tradeName>
    <deviceName>CYFRA21-1 Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4298109</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:57:13.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4298106K2</udiDi>
    <basicUdiDi>B-EIM4298106K2</basicUdiDi>
    <tradeName>D-EIM4298106K2</tradeName>
    <deviceName>Chemiluminescent Immunoassay Controls for Tumor Marker 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4298106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:57:12.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4297507KH</udiDi>
    <basicUdiDi>B-EIM4297507KH</basicUdiDi>
    <tradeName>D-EIM4297507KH</tradeName>
    <deviceName>Maternal 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4297507</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:57:07.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4297505KD</udiDi>
    <basicUdiDi>B-EIM4297505KD</basicUdiDi>
    <tradeName>D-EIM4297505KD</tradeName>
    <deviceName>Insulin &amp; C-Peptide 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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4297505</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:57:07.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4297112JN</udiDi>
    <basicUdiDi>B-EIM4297112JN</basicUdiDi>
    <tradeName>D-EIM4297112JN</tradeName>
    <deviceName>CA50 Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4297112</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:56:48.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4297111JL</udiDi>
    <basicUdiDi>B-EIM4297111JL</basicUdiDi>
    <tradeName>D-EIM4297111JL</tradeName>
    <deviceName>SCC Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4297111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:56:48.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4297109JZ</udiDi>
    <basicUdiDi>B-EIM4297109JZ</basicUdiDi>
    <tradeName>D-EIM4297109JZ</tradeName>
    <deviceName>CYFRA21-1 Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4297109</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:56:44.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4297106JT</udiDi>
    <basicUdiDi>B-EIM4297106JT</basicUdiDi>
    <tradeName>D-EIM4297106JT</tradeName>
    <deviceName>Chemiluminescent Immunoassay Controls for Tumor Marker 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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4297106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:56:43.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4296567KU</udiDi>
    <basicUdiDi>B-EIM4296567KU</basicUdiDi>
    <tradeName>D-EIM4296567KU</tradeName>
    <deviceName>NSE Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4296567</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:56:41.643Z</lastUpdated>
  </row>
</eudamedExport>