<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08908007989965</udiDi>
    <basicUdiDi>8908007989965DD</basicUdiDi>
    <tradeName>Truelab® Quattro</tradeName>
    <deviceName>Truelab® Quattro Real Time Quantitative micro PCR Analyzer</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>603023001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:18.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989958</udiDi>
    <basicUdiDi>8908007989958DG</basicUdiDi>
    <tradeName>Truelab® Duo</tradeName>
    <deviceName>Truelab® Duo Real Time Quantitative micro PCR Analyzer</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>603022001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:18.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989941</udiDi>
    <basicUdiDi>8908007989941CX</basicUdiDi>
    <tradeName>Truelab® Uno Dx</tradeName>
    <deviceName>Truelab® Uno Dx Real Time Quantitative micro PCR Analyzer</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>603021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:14.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998275996</udiDi>
    <basicUdiDi>868459503MGX32QC</basicUdiDi>
    <tradeName>MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-32</tradeName>
    <deviceName>Magnetic Bead-Based Automated NA Extraction System - MGX-32</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGX-32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:39:40.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595032350</udiDi>
    <basicUdiDi>868459503MGX16QE</basicUdiDi>
    <tradeName>MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-16</tradeName>
    <deviceName>Magnetic Bead-Based Automated NA Extraction System - MGX-16</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGX-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:37:24.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595032343</udiDi>
    <basicUdiDi>868459503MGX2RM</basicUdiDi>
    <tradeName>MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-2</tradeName>
    <deviceName>Magnetic Bead-Based Automated NA Extraction System - MGX-2</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGX-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:37:21.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975614169044</udiDi>
    <basicUdiDi>697561416NAT1N7</basicUdiDi>
    <tradeName>06975614169044</tradeName>
    <deviceName>Fully-Automated Nucleic Acid Amplification Testing System</deviceName>
    <manufacturerName>Genewise Bio Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038313</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NAT-3000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:24:15.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975491760174</udiDi>
    <basicUdiDi>697549176ADEAMIPM</basicUdiDi>
    <tradeName>06975491760174</tradeName>
    <deviceName>Automatic DNA Extraction and Methylation instrument</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEP-8</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:33.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975491760181</udiDi>
    <basicUdiDi>697549176ADEAMIPM</basicUdiDi>
    <tradeName>06975491760181</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEP-32</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:39.404Z</lastUpdated>
  </row>
</eudamedExport>