<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FEFER-PN20HGC8</udiDi>
    <basicUdiDi>B-FEFER-PN20HGC8</basicUdiDi>
    <tradeName>FERR Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FEFER-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:26:38.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FEFER-PN2077</udiDi>
    <basicUdiDi>B-FEFER-PN2077</basicUdiDi>
    <tradeName>FERR Control</tradeName>
    <deviceName>FERR Control</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FEFER-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:26:34.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-469905S3</udiDi>
    <basicUdiDi>B-469905S3</basicUdiDi>
    <tradeName>Vigil™ Lipid Control Level 1</tradeName>
    <deviceName>Vigil™ Lipid Control Level 1</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469905</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:32.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-465982RR</udiDi>
    <basicUdiDi>B-465982RR</basicUdiDi>
    <tradeName>Vigil™ Lipid Control Level 4</tradeName>
    <deviceName>Vigil™ Lipid Control Level 4</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>465982</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:37.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-465981RP</udiDi>
    <basicUdiDi>B-465981RP</basicUdiDi>
    <tradeName>Vigil™ Lipid Control Level 3</tradeName>
    <deviceName>Vigil™ Lipid Control Level 3</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>465981</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:36.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-465980RM</udiDi>
    <basicUdiDi>B-465980RM</basicUdiDi>
    <tradeName>Vigil™ Lipid Control Level 2</tradeName>
    <deviceName>Vigil™ Lipid Control Level 2</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>465980</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:36.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-450125NP</udiDi>
    <basicUdiDi>B-450125NP</basicUdiDi>
    <tradeName>Vigil Protein Control Level 2</tradeName>
    <deviceName>Vigil Protein Control Level 2</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450125</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:48:14.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-450120ND</udiDi>
    <basicUdiDi>B-450120ND</basicUdiDi>
    <tradeName>Vigil Protein Control Level 1</tradeName>
    <deviceName>Vigil Protein Control Level 1</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:48:09.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3000-2339DM</udiDi>
    <basicUdiDi>B-3000-2339DM</basicUdiDi>
    <tradeName>sTfR (II) Controls</tradeName>
    <deviceName>sTfR (II) Controls</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-2339</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:06:25.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414600376</udiDi>
    <basicUdiDi>0405686900804VK</basicUdiDi>
    <tradeName>Atellica IM Vitamin D Total Quality Control (VitD QC)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995724</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:46:10.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700828013</udiDi>
    <basicUdiDi>37017008VITD05FF</basicUdiDi>
    <tradeName>VITAMIN D CONTROL SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VITD-4630</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700828020</udiDi>
    <basicUdiDi>37017008VITD05FF</basicUdiDi>
    <tradeName>VITAMIN D CONTROL SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VITD-4730</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:24.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469760289</udiDi>
    <basicUdiDi>B-06979469760289</basicUdiDi>
    <tradeName>Quality Control (25-OH-VD)</tradeName>
    <deviceName>Quality Control (25-OH-VD)</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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D5801Q</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:18.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469760135</udiDi>
    <basicUdiDi>B-06979469760135</basicUdiDi>
    <tradeName>Quality Control (Ferritin)</tradeName>
    <deviceName>Quality Control (Ferritin)</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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N1802Q</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:05.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469760128</udiDi>
    <basicUdiDi>B-06979469760128</basicUdiDi>
    <tradeName>Quality Control (Ferritin)</tradeName>
    <deviceName>Quality Control (Ferritin)</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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N1801Q</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:01.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415335</udiDi>
    <basicUdiDi>B-06978896415335</basicUdiDi>
    <tradeName>Ferritin Control</tradeName>
    <deviceName>Ferritin 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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-C-Fer-1</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:47:28.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977565586833</udiDi>
    <basicUdiDi>B-06977565586833</basicUdiDi>
    <tradeName>Anemia Control</tradeName>
    <deviceName>Anemia Control</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6832</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:23:22.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521003601</udiDi>
    <basicUdiDi>B-06974521003601</basicUdiDi>
    <tradeName>CLIA FA Control</tradeName>
    <deviceName>CLIA FA 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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MQC029</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:37:07.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521001386</udiDi>
    <basicUdiDi>B-06974521001386</basicUdiDi>
    <tradeName>CLIA VB12 Control</tradeName>
    <deviceName>CLIA VB12 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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MQC030</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:11.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521001232</udiDi>
    <basicUdiDi>B-06974521001232</basicUdiDi>
    <tradeName>CLIA FERR Control</tradeName>
    <deviceName>CLIA FERR 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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MQC031</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:29:33.620Z</lastUpdated>
  </row>
</eudamedExport>