<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974643920138</udiDi>
    <basicUdiDi>697464392METH01RW</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR)</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR)</deviceName>
    <manufacturerName>ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000015645</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EH001C-50 50 tests/kit</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:13:54.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970895475822</udiDi>
    <basicUdiDi>B-06970895475822</basicUdiDi>
    <tradeName>06970895475822</tradeName>
    <deviceName>Human Telomere Length Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TP060101T2024</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:08.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970895475792</udiDi>
    <basicUdiDi>B-06970895475792</basicUdiDi>
    <tradeName>06970895475792</tradeName>
    <deviceName>Human Telomere Length Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TP060101T2048</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:07.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341688141</udiDi>
    <basicUdiDi>B-06970341688141</basicUdiDi>
    <tradeName>06970341688141</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>528007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:28.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341688134</udiDi>
    <basicUdiDi>B-06970341688134</basicUdiDi>
    <tradeName>06970341688134</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>528006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:27.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959094214869</udiDi>
    <basicUdiDi>69590942A0037GP</basicUdiDi>
    <tradeName>AmoyDx® AutoExtract Kit (Circulating DNA)</tradeName>
    <deviceName>AmoyDx® AutoExtract Kit (Circulating DNA)</deviceName>
    <manufacturerName>Amoy Diagnostics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021843</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.02.0148</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:31:50.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959094214838</udiDi>
    <basicUdiDi>69590942A0036GM</basicUdiDi>
    <tradeName>AmoyDx® AutoExtract Kit (FFPE DNA)</tradeName>
    <deviceName>AmoyDx® AutoExtract Kit (FFPE DNA)</deviceName>
    <manufacturerName>Amoy Diagnostics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021843</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.02.0147</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:31:49.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006019</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Dynamag™ 96-Well Plate Dx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A31347 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006125</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Ion PGM™ Dx Library Reagents</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18928 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006132</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Ion OneTouch™ Dx Template Supplies</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18933 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006149</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Ion PGM™ Dx Sequencing Supplies</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18936 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006163</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Ion PGM™ Dx Library Equalizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18929 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006187</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Ion PGM™ Dx Library Equalizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18930 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006194</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Ion OneTouch™ Dx Template ES Beads</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18931 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006200</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Ion OneTouch™ Dx Template Solutions</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18932 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006224</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Ion PGM™ Dx Sequencing Reagents</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18934 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006231</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Ion PGM™ Dx Sequencing Solutions</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18935 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006255</udiDi>
    <basicUdiDi>0190302A25512RD</basicUdiDi>
    <tradeName>Ion PGM™ 318™ Dx Chip Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18937 (A25512, A43412, A43413, A43414, A27218)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:08.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302017480</udiDi>
    <basicUdiDi>0190302A50430R8</basicUdiDi>
    <tradeName>Genexus™ Dx Strip 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50862 (A50430, A50430RR)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:07.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302017503</udiDi>
    <basicUdiDi>0190302A50431RA</basicUdiDi>
    <tradeName>Genexus™ Dx Strip 3-GX5™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50864 (A50431)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:50:52.997Z</lastUpdated>
  </row>
</eudamedExport>