<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10190302014090</udiDi>
    <basicUdiDi>0190302A25511RB</basicUdiDi>
    <tradeName>Torrent Suite™ Dx SW v5.8 Installer</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>A36601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:07.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302016155</udiDi>
    <basicUdiDi>0190302TCF00005354P</basicUdiDi>
    <tradeName>QuantStudio™ 7 Pro Dx 96-Well Block</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>A51195</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:07.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302016162</udiDi>
    <basicUdiDi>0190302TCF00005354P</basicUdiDi>
    <tradeName>QuantStudio™ 7 Pro Dx 96-Well Heated Cover</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>A51197</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:07.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302016810</udiDi>
    <basicUdiDi>0190302A25511RB</basicUdiDi>
    <tradeName>Torrent Suite™ DX SW, Installer v5.12.5</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>A46166</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:07.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302017329</udiDi>
    <basicUdiDi>0190302TCF00005354P</basicUdiDi>
    <tradeName>QuantStudio™ 7 Pro Dx 384-Well Block</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>A51220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:07.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302017336</udiDi>
    <basicUdiDi>0190302TCF00005354P</basicUdiDi>
    <tradeName>QuantStudio™ 7 Pro Dx 384-Well Heated Cover</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>A51222</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:51:07.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302017848</udiDi>
    <basicUdiDi>0190302A25511RB</basicUdiDi>
    <tradeName>Torrent Suite™ DX SW, Installer V5.14</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>A52422</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:50:52.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302017961</udiDi>
    <basicUdiDi>0190302A47326SJ</basicUdiDi>
    <tradeName>QuantStudio™ 5 Dx Software</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>A54067 (A47326, A47327)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:50:52.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302019958</udiDi>
    <basicUdiDi>0190302A25511RB</basicUdiDi>
    <tradeName>Torrent Suite™ DX SW, Updater V5.14.2</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>A40001728</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:50:51.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809886490019</udiDi>
    <basicUdiDi>880988649HWTPC-NC15PLUSL4</basicUdiDi>
    <tradeName>08809886490019</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HANWOOLTPC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026674</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</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>HWTD-01-48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:46.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809886490026</udiDi>
    <basicUdiDi>880988649HWTPC-NC15PLUSL4</basicUdiDi>
    <tradeName>08809886490026</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HANWOOLTPC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026674</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</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>YETS0001EG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:46.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809886490033</udiDi>
    <basicUdiDi>880988649HWTPC-NC15PLUSL4</basicUdiDi>
    <tradeName>Real-Prep</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HANWOOLTPC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026674</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</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>BS-K00015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:46.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809886490040</udiDi>
    <basicUdiDi>880988649HWTPC-NC15PLUSL4</basicUdiDi>
    <tradeName>SGPrep32</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HANWOOLTPC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026674</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</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>SGprep-180701</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:46.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809886490057</udiDi>
    <basicUdiDi>880988649HWTPC-NC15PLUSL4</basicUdiDi>
    <tradeName>SWH-EM48</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HANWOOLTPC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026674</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</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>SH-CEK-02-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:46.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809886490064</udiDi>
    <basicUdiDi>880988649HWTPC-NC15PLUSL4</basicUdiDi>
    <tradeName>GenetreEX™ 32</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HANWOOLTPC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026674</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</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>GenetreEX-01-32</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:00:46.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731318</udiDi>
    <basicUdiDi>69557927SQ31B0000001J5</basicUdiDi>
    <tradeName>Portable Molecule Workstation</tradeName>
    <deviceName>Portable Molecule Workstation</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S-Q31B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:30:52.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731301</udiDi>
    <basicUdiDi>69557927SQ31A0000001HJ</basicUdiDi>
    <tradeName>Portable Molecule Workstation</tradeName>
    <deviceName>Portable Molecule Workstation</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S-Q31A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:30:50.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730496</udiDi>
    <basicUdiDi>69557927SQ3600000001BM</basicUdiDi>
    <tradeName>Portable Molecular Workstation</tradeName>
    <deviceName>Portable Molecular Workstation</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S-Q36B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:05.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730489</udiDi>
    <basicUdiDi>69557927SQ35C0000001ML</basicUdiDi>
    <tradeName>Nucleic Acid Analysis Device</tradeName>
    <deviceName>Nucleic Acid Analysis Device</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S-Q35C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:02.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730472</udiDi>
    <basicUdiDi>69557927SQ3600000001BM</basicUdiDi>
    <tradeName>Portable Molecular Workstation</tradeName>
    <deviceName>Portable Molecular Workstation</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</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>S-Q36A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:27:58.446Z</lastUpdated>
  </row>
</eudamedExport>