<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06979469760067</udiDi>
    <basicUdiDi>B-06979469760067</basicUdiDi>
    <tradeName>Quality Control (CEA)</tradeName>
    <deviceName>Quality Control (CEA)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M3801Q</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:39:55.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469760074</udiDi>
    <basicUdiDi>B-06979469760074</basicUdiDi>
    <tradeName>Quality Control (CEA)</tradeName>
    <deviceName>Quality Control (CEA)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M3802Q</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:39:53.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415366</udiDi>
    <basicUdiDi>B-06978896415366</basicUdiDi>
    <tradeName>AFP Control</tradeName>
    <deviceName>AFP Control</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-C-AFP-1</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:47:34.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415359</udiDi>
    <basicUdiDi>B-06978896415359</basicUdiDi>
    <tradeName>CEA Control</tradeName>
    <deviceName>CEA Control</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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-C-CEA-1</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:47:34.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974873630333</udiDi>
    <basicUdiDi>B-06974873630333</basicUdiDi>
    <tradeName>06974873630333</tradeName>
    <deviceName>Human Tumor Specific Protein 70 Circulating Tumor Cell Control 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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD7003-C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:01:24.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974873630104</udiDi>
    <basicUdiDi>B-06974873630104</basicUdiDi>
    <tradeName>06974873630104</tradeName>
    <deviceName>Human Tumor Specific Protein 70 ELISA Control 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>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD7001-C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:01:18.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003403</udiDi>
    <basicUdiDi>B-06974521003403</basicUdiDi>
    <tradeName>β2-MG Control</tradeName>
    <deviceName>β2-MG Control</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC704</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:36:34.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003205</udiDi>
    <basicUdiDi>B-06974521003205</basicUdiDi>
    <tradeName>CEA Control</tradeName>
    <deviceName>CEA Control</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC503</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:34:17.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003199</udiDi>
    <basicUdiDi>B-06974521003199</basicUdiDi>
    <tradeName>AFP Control</tradeName>
    <deviceName>AFP Control</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC502</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:34:16.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521001171</udiDi>
    <basicUdiDi>B-06974521001171</basicUdiDi>
    <tradeName>CLIA CEA Control</tradeName>
    <deviceName>CLIA CEA Control</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MQC026</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:29:22.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521001140</udiDi>
    <basicUdiDi>B-06974521001140</basicUdiDi>
    <tradeName>CLIA AFP Control</tradeName>
    <deviceName>CLIA AFP Control</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MQC025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:29:20.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904096902</udiDi>
    <basicUdiDi>69449040004L-TM-Con****UY</basicUdiDi>
    <tradeName>Tumor Marker Multi Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-007374-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:01.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883003804</udiDi>
    <basicUdiDi>B-00884883003804</basicUdiDi>
    <tradeName>00884883003804</tradeName>
    <deviceName>MAS® T-Marker Liquid Assayed Tumor Marker Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUM-S1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:38.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002463</udiDi>
    <basicUdiDi>B-00884883002463</basicUdiDi>
    <tradeName>00884883002463</tradeName>
    <deviceName>MAS® T-Marker Liquid Assayed Tumor Marker Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUM-303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:14:57.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002456</udiDi>
    <basicUdiDi>B-00884883002456</basicUdiDi>
    <tradeName>00884883002456</tradeName>
    <deviceName>MAS® T-Marker Liquid Assayed Tumor Marker Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUM-202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:14:57.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002449</udiDi>
    <basicUdiDi>B-00884883002449</basicUdiDi>
    <tradeName>00884883002449</tradeName>
    <deviceName>MAS® T-Marker Liquid Assayed Tumor Marker Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUM-101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:14:55.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005739</udiDi>
    <basicUdiDi>B-00859110005739</basicUdiDi>
    <tradeName>VALIDATE® TUMOR MARKERS Test Set</tradeName>
    <deviceName>VALIDATE® TUMOR MARKERS Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407sa</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:41:16.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005722</udiDi>
    <basicUdiDi>B-00859110005722</basicUdiDi>
    <tradeName>VALIDATE® TUMOR MARKERS Test Set</tradeName>
    <deviceName>VALIDATE® TUMOR MARKERS Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407re</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:41:16.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850011135266</udiDi>
    <basicUdiDi>B-00850011135266</basicUdiDi>
    <tradeName>VALIDATE® TUMOR MARKERS Test Set</tradeName>
    <deviceName>VALIDATE® TUMOR MARKERS Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>407ab</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:58:31.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133048511</udiDi>
    <basicUdiDi>880613306142D2</basicUdiDi>
    <tradeName>Boditech Free PSA Control</tradeName>
    <deviceName>Boditech Free PSA Control</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-406</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:27.210Z</lastUpdated>
  </row>
</eudamedExport>