<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-1897K</udiDi>
    <basicUdiDi>B-1897K</basicUdiDi>
    <tradeName>D-1897K</tradeName>
    <deviceName>Sialic Acid Assay Kit (Enzymatic Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:16:07.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912734321</udiDi>
    <basicUdiDi>692591270279J2</basicUdiDi>
    <tradeName>iFlash-Total β HCG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86327</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:12.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912734338</udiDi>
    <basicUdiDi>692591270279J2</basicUdiDi>
    <tradeName>iFlash-Total β HCG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86327-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:12.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-07LE8300R7</udiDi>
    <basicUdiDi>B-07LE8300R7</basicUdiDi>
    <tradeName>2-MET Plasma ELISA Fast Track</tradeName>
    <deviceName>2-MET Plasma ELISA Fast Track</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07LE8300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:23.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975977120102</udiDi>
    <basicUdiDi>B-06975977120102</basicUdiDi>
    <tradeName>06975977120102</tradeName>
    <deviceName>EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Genebiohealth Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046424</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPC010-100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:59.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975977120096</udiDi>
    <basicUdiDi>B-06975977120096</basicUdiDi>
    <tradeName>06975977120096</tradeName>
    <deviceName>EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Genebiohealth Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046424</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPC010-50</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:55.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975977120089</udiDi>
    <basicUdiDi>B-06975977120089</basicUdiDi>
    <tradeName>06975977120089</tradeName>
    <deviceName>EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Genebiohealth Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046424</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPC010-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:54.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986814309</udiDi>
    <basicUdiDi>B-06974986814309</basicUdiDi>
    <tradeName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:22:55.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986813074</udiDi>
    <basicUdiDi>B-06974986813074</basicUdiDi>
    <tradeName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:19:16.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986813067</udiDi>
    <basicUdiDi>B-06974986813067</basicUdiDi>
    <tradeName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:19:15.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974873630340</udiDi>
    <basicUdiDi>B-06974873630340</basicUdiDi>
    <tradeName>06974873630340</tradeName>
    <deviceName>Human Tumor Specific Protein 70 Pleural Effusion Circulating Tumor Cell Kit</deviceName>
    <manufacturerName>Jiangsu Code Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048158</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD700302-50</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:01:25.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974873630326</udiDi>
    <basicUdiDi>B-06974873630326</basicUdiDi>
    <tradeName>06974873630326</tradeName>
    <deviceName>Human Tumor Specific Protein 70 Pleural Effusion Circulating Tumor Cell Kit</deviceName>
    <manufacturerName>Jiangsu Code Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048158</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD700302-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:01:23.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974873630098</udiDi>
    <basicUdiDi>B-06974873630098</basicUdiDi>
    <tradeName>06974873630098</tradeName>
    <deviceName>Human Tumor Specific Protein 70 ELISA Kit</deviceName>
    <manufacturerName>Jiangsu Code Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048158</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD7001-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:01:17.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973720135694</udiDi>
    <basicUdiDi>B-06973720135694</basicUdiDi>
    <tradeName>06973720135694</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF-AFP-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:32:51.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973720135687</udiDi>
    <basicUdiDi>B-06973720135687</basicUdiDi>
    <tradeName>06973720135687</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF-AFP-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:32:50.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719607082</udiDi>
    <basicUdiDi>B-06972719607082</basicUdiDi>
    <tradeName>06972719607082</tradeName>
    <deviceName>Vascular Endothelial Growth Factor Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:56:24.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719607075</udiDi>
    <basicUdiDi>B-06972719607075</basicUdiDi>
    <tradeName>06972719607075</tradeName>
    <deviceName>Vascular Endothelial Growth Factor Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:56:20.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719606269</udiDi>
    <basicUdiDi>B-06972719606269</basicUdiDi>
    <tradeName>06972719606269</tradeName>
    <deviceName>Vascular Endothelial Growth Factor Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:52:17.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719606252</udiDi>
    <basicUdiDi>B-06972719606252</basicUdiDi>
    <tradeName>06972719606252</tradeName>
    <deviceName>Vascular Endothelial Growth Factor Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:52:17.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719606245</udiDi>
    <basicUdiDi>B-06972719606245</basicUdiDi>
    <tradeName>06972719606245</tradeName>
    <deviceName>Vascular Endothelial Growth Factor Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:52:13.338Z</lastUpdated>
  </row>
</eudamedExport>