<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936895301172</udiDi>
    <basicUdiDi>6936895BS0082G</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-HS96A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:04.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895301189</udiDi>
    <basicUdiDi>6936895BS0082G</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-HS96B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:04.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895301196</udiDi>
    <basicUdiDi>6936895BS0082G</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-HS96C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:04.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895301202</udiDi>
    <basicUdiDi>6936895BS0082G</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-HS96D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:04.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895301219</udiDi>
    <basicUdiDi>6936895BS0082G</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-HS96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:04.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302005944</udiDi>
    <basicUdiDi>0190302TCF00005084L</basicUdiDi>
    <tradeName>3500xL Dx Genetic Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>4405183 (A27856)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T09:58:39.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302018876</udiDi>
    <basicUdiDi>0190302A50534RM</basicUdiDi>
    <tradeName>Applied Biosystems™ SeqStudio™ 24 Flex Dx Genetic Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A50535</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T09:58:39.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103080443</udiDi>
    <basicUdiDi>69281030804XFX</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction Instrument</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA8044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>06928103080450</udiDi>
    <basicUdiDi>69281030804XFX</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction Instrument</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA8045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:40:00.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967205203</udiDi>
    <basicUdiDi>697326286000792G</basicUdiDi>
    <tradeName>Quantitative Real-time PCR System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02-17-01-0024-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T17:47:17.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967205197</udiDi>
    <basicUdiDi>697326286000792G</basicUdiDi>
    <tradeName>Quantitative Real-time PCR System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02-17-01-0023-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T17:47:16.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967205180</udiDi>
    <basicUdiDi>697326286000792G</basicUdiDi>
    <tradeName>Quantitative Real-time PCR System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02-17-01-0022-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T17:47:15.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500552</udiDi>
    <basicUdiDi>069370445acapeW9</basicUdiDi>
    <tradeName>06937044500552</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01010010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:15.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500545</udiDi>
    <basicUdiDi>069370445sseqA02010001JE</basicUdiDi>
    <tradeName>06937044500545</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02010011</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:13.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500293</udiDi>
    <basicUdiDi>069370445anucaA03010004XS</basicUdiDi>
    <tradeName>06937044500293</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A03010017</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:46.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500286</udiDi>
    <basicUdiDi>069370445anucaA03010003XQ</basicUdiDi>
    <tradeName>06937044500286</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A03010010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:45.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500279</udiDi>
    <basicUdiDi>069370445anucaA03010002XN</basicUdiDi>
    <tradeName>06937044500279</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A03010010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:42.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500262</udiDi>
    <basicUdiDi>069370445anucaA03010001XL</basicUdiDi>
    <tradeName>06937044500262</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A03010010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:41.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072985040</udiDi>
    <basicUdiDi>471307298G1QT</basicUdiDi>
    <tradeName>Vircell Molecular Analysis POC System G1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>VG1MD</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713072985071</udiDi>
    <basicUdiDi>471307298G1QT</basicUdiDi>
    <tradeName>DELBIO Automated Nucleic Acid Analysis System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DELBIO INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000003400</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>G1-03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:54.748Z</lastUpdated>
  </row>
</eudamedExport>