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<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4406114JA</udiDi>
    <basicUdiDi>B-IM4406114JA</basicUdiDi>
    <tradeName>D-IM4406114JA</tradeName>
    <deviceName>CA 242 Chemiluminescent Immunoassay Kit</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>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406114</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:21.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406113J8</udiDi>
    <basicUdiDi>B-IM4406113J8</basicUdiDi>
    <tradeName>D-IM4406113J8</tradeName>
    <deviceName>CA 72-4 Chemiluminescent Immunoassay Kit</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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406113</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:19.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406112J6</udiDi>
    <basicUdiDi>B-IM4406112J6</basicUdiDi>
    <tradeName>D-IM4406112J6</tradeName>
    <deviceName>proGRP Chemiluminescent Immunoassay Kit</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>W0102030121</emdnCode>
    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406112</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:17.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406111J4</udiDi>
    <basicUdiDi>B-IM4406111J4</basicUdiDi>
    <tradeName>D-IM4406111J4</tradeName>
    <deviceName>SCC Chemiluminescent Immunoassay Kit</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>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:15.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406109JH</udiDi>
    <basicUdiDi>B-IM4406109JH</basicUdiDi>
    <tradeName>D-IM4406109JH</tradeName>
    <deviceName>CYFRA21-1 Chemiluminescent Immunoassay Kit</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>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406109</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:13.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406110J2</udiDi>
    <basicUdiDi>B-IM4406110J2</basicUdiDi>
    <tradeName>D-IM4406110J2</tradeName>
    <deviceName>CA 50 Chemiluminescent Immunoassay Kit</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>W0102030104</emdnCode>
    <emdnDescription>CANCER ANTIGEN 50</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406110</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:11.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403129J2</udiDi>
    <basicUdiDi>B-IM4403129J2</basicUdiDi>
    <tradeName>D-IM4403129J2</tradeName>
    <deviceName>PIVKA-II Chemiluminescent Immunoassay Kit</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>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403129</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:14.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403115HP</udiDi>
    <basicUdiDi>B-IM4403115HP</basicUdiDi>
    <tradeName>D-IM4403115HP</tradeName>
    <deviceName>HE4 Chemiluminescent Immunoassay Kit</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>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403115</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:08.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403114HM</udiDi>
    <basicUdiDi>B-IM4403114HM</basicUdiDi>
    <tradeName>D-IM4403114HM</tradeName>
    <deviceName>CA 242 Chemiluminescent Immunoassay Kit</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>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403114</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:07.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403113HK</udiDi>
    <basicUdiDi>B-IM4403113HK</basicUdiDi>
    <tradeName>D-IM4403113HK</tradeName>
    <deviceName>CA 72-4 Chemiluminescent Immunoassay Kit</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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403113</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:07.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403112HH</udiDi>
    <basicUdiDi>B-IM4403112HH</basicUdiDi>
    <tradeName>D-IM4403112HH</tradeName>
    <deviceName>proGRP Chemiluminescent Immunoassay Kit</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>W0102030121</emdnCode>
    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403112</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:19:52.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403111HF</udiDi>
    <basicUdiDi>B-IM4403111HF</basicUdiDi>
    <tradeName>D-IM4403111HF</tradeName>
    <deviceName>SCC Chemiluminescent Immunoassay Kit</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>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:19:51.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403110HD</udiDi>
    <basicUdiDi>B-IM4403110HD</basicUdiDi>
    <tradeName>D-IM4403110HD</tradeName>
    <deviceName>CA 50 Chemiluminescent Immunoassay Kit</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>W0102030104</emdnCode>
    <emdnDescription>CANCER ANTIGEN 50</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403110</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:19:50.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403109HU</udiDi>
    <basicUdiDi>B-IM4403109HU</basicUdiDi>
    <tradeName>D-IM4403109HU</tradeName>
    <deviceName>CYFRA21-1 Chemiluminescent Immunoassay Kit</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>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403109</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:19:50.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402129HT</udiDi>
    <basicUdiDi>B-IM4402129HT</basicUdiDi>
    <tradeName>D-IM4402129HT</tradeName>
    <deviceName>PIVKA-II Chemiluminescent Immunoassay Kit</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>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402129</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:49.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402115HG</udiDi>
    <basicUdiDi>B-IM4402115HG</basicUdiDi>
    <tradeName>D-IM4402115HG</tradeName>
    <deviceName>HE4 Chemiluminescent Immunoassay Kit</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>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402115</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:44.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402114HE</udiDi>
    <basicUdiDi>B-IM4402114HE</basicUdiDi>
    <tradeName>D-IM4402114HE</tradeName>
    <deviceName>CA 242 Chemiluminescent Immunoassay Kit</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>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402114</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:43.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402113HC</udiDi>
    <basicUdiDi>B-IM4402113HC</basicUdiDi>
    <tradeName>D-IM4402113HC</tradeName>
    <deviceName>CA 72-4 Chemiluminescent Immunoassay Kit</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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402113</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:42.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402112HA</udiDi>
    <basicUdiDi>B-IM4402112HA</basicUdiDi>
    <tradeName>D-IM4402112HA</tradeName>
    <deviceName>proGRP Chemiluminescent Immunoassay Kit</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>W0102030121</emdnCode>
    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402112</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:41.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402111H8</udiDi>
    <basicUdiDi>B-IM4402111H8</basicUdiDi>
    <tradeName>D-IM4402111H8</tradeName>
    <deviceName>SCC Chemiluminescent Immunoassay Kit</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>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:37.898Z</lastUpdated>
  </row>
</eudamedExport>