<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06956299702108</udiDi>
    <basicUdiDi>695629970002NZ</basicUdiDi>
    <tradeName>Sanity 2.0 System</tradeName>
    <deviceName>Fully Automated Medical PCR Analysis System</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>505101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:31:25.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956299702030</udiDi>
    <basicUdiDi>695629970003P3</basicUdiDi>
    <tradeName>Nucleic Acid Extraction System</tradeName>
    <deviceName>Nucleic Acid Extraction System</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>501110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:31:25.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955931304250</udiDi>
    <basicUdiDi>695593130023090804MC</basicUdiDi>
    <tradeName>Automatic Integrated Nucleic Acid Analyzer</tradeName>
    <deviceName>Automatic Integrated Nucleic Acid Analyzer</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2309HD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:07.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955931304243</udiDi>
    <basicUdiDi>695593130023080807M7</basicUdiDi>
    <tradeName>Fully Automated Nucleic Acid Amplification Hybridization Analyzer</tradeName>
    <deviceName>Fully Automated Nucleic Acid Amplification Hybridization Analyzer</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2308HG</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:03.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895300120</udiDi>
    <basicUdiDi>6936895BS0082G</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction System</tradeName>
    <deviceName>Automatic Nucleic Acid Extraction System</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:00:17.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289850568</udiDi>
    <basicUdiDi>69332898CE3186FW</basicUdiDi>
    <tradeName>U-CardDxTM 200</tradeName>
    <deviceName>Automated Rapid Molecular Diagnostic System</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>WK52</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:55:57.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103083000</udiDi>
    <basicUdiDi>69281030830XG2</basicUdiDi>
    <tradeName>06928103083000</tradeName>
    <deviceName>Nucleic Acid Extraction Instrument</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA8300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:46:17.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103081303</udiDi>
    <basicUdiDi>69281030813XFZ</basicUdiDi>
    <tradeName>Rapid Detection System</tradeName>
    <deviceName>Rapid Detection System</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA8130</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:46:13.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103080429</udiDi>
    <basicUdiDi>69281030804XFX</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction Instrument</tradeName>
    <deviceName>Automatic Nucleic Acid Extraction Instrument</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA8042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:46:11.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103081204</udiDi>
    <basicUdiDi>69281030812XFW</basicUdiDi>
    <tradeName>Real-time PCR Detection System</tradeName>
    <deviceName>Real-time PCR Detection System</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA8120</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:46:11.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103080306</udiDi>
    <basicUdiDi>69281030803XFU</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Instrument</tradeName>
    <deviceName>Nucleic Acid Extraction Instrument</deviceName>
    <manufacturerName>Daan Gene Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025799</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA8030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:55.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921807600948</udiDi>
    <basicUdiDi>692180760094FA</basicUdiDi>
    <tradeName>Real-Time PCR System Lepgen-96</tradeName>
    <deviceName>Real-Time PCR System Lepgen-96</deviceName>
    <manufacturerName>BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033011</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JY18Lepgen-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:11:07.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438556100204</udiDi>
    <basicUdiDi>6438556CDX-10RB</basicUdiDi>
    <tradeName>GenomEra CDX System</tradeName>
    <deviceName>GenomEra CDX System</deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-10-020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:55:11.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468355</udiDi>
    <basicUdiDi>5745000468EU02000400019E</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Hand-held Nucleic Acid Detection Analyzer</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0200040001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:40:27.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700574036843</udiDi>
    <basicUdiDi>570057R0802P3011A040400SD</basicUdiDi>
    <tradeName>AriaDx Real-Time PCR Instrument</tradeName>
    <deviceName>AriaDx Real-Time PCR Instrument</deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K8930A</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:54:40.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415219001390</udiDi>
    <basicUdiDi>5415219P1030H2</basicUdiDi>
    <tradeName>Idylla™ Hub</tradeName>
    <deviceName>Idylla™ Hub</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1030</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:53:27.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415219000126</udiDi>
    <basicUdiDi>5415219P1010GU</basicUdiDi>
    <tradeName>Idylla™ Console</tradeName>
    <deviceName>Idylla™ Console</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:53:21.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415219000119</udiDi>
    <basicUdiDi>5415219P0010GM</basicUdiDi>
    <tradeName>Idylla™ Instrument</tradeName>
    <deviceName>Idylla™ Instrument</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P0010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:53:20.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987869127009</udiDi>
    <basicUdiDi>4987869geneLEAD8S</basicUdiDi>
    <tradeName>geneLEAD VIII</tradeName>
    <deviceName>geneLEAD VIII</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2700</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:49.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987869122400</udiDi>
    <basicUdiDi>4987869geneLEAD24UE</basicUdiDi>
    <tradeName>geneLEAD XXIV</tradeName>
    <deviceName>geneLEAD XXIV</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:48.010Z</lastUpdated>
  </row>
</eudamedExport>