<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>None</udiDi>
    <basicUdiDi>++G143TC8MagneticMixerY5</basicUdiDi>
    <tradeName>T-COR 8 Magnetic Mixer</tradeName>
    <deviceName>T-COR 8 Magnetic Mixer</deviceName>
    <manufacturerName>Tetracore INC</manufacturerName>
    <manufacturerSrn>US-MF-000023064</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC-5018-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:39:28.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>NA</udiDi>
    <basicUdiDi>++G143TC8RTPCRInstKF</basicUdiDi>
    <tradeName>T-COR 8</tradeName>
    <deviceName>T-COR 8</deviceName>
    <manufacturerName>Tetracore INC</manufacturerName>
    <manufacturerSrn>US-MF-000023064</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC-5049-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:39:26.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRVCNUPR1</udiDi>
    <basicUdiDi>++EVIRSoftware98</basicUdiDi>
    <tradeName>ViraChip Software</tradeName>
    <deviceName>Software</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050292</emdnCode>
    <emdnDescription>MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-VCNUPR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:33.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EVIRUVCSCA1</udiDi>
    <basicUdiDi>++EVIRLaboratoryDeviceFP</basicUdiDi>
    <tradeName>ViraChip Scanner</tradeName>
    <deviceName>Laboratory Device</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050107</emdnCode>
    <emdnDescription>MICRO-ARRAY SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-UVCSCA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:21:37.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-knowliter-1KS</udiDi>
    <basicUdiDi>B-knowliter-1KS</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>KNOWLITER software</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>knowliter-1</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:20:00.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000023929A538508G</udiDi>
    <basicUdiDi>B-USMF000023929A538508G</basicUdiDi>
    <tradeName>Low-pass whole-genome aneuploidy Dx Mosaic w1.0</tradeName>
    <deviceName>Low-pass whole-genome aneuploidy Dx Mosaic w1.0, a part of Ion Reporter (IR) Software Aneuploidy Dx Workflows</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A53850</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:47:34.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000023929A538488V</udiDi>
    <basicUdiDi>B-USMF000023929A538488V</basicUdiDi>
    <tradeName>Low-pass whole-genome aneuploidy Dx w1.0</tradeName>
    <deviceName>Low-pass whole-genome aneuploidy Dx w1.0, a part of Ion Reporter (IR) Software Aneuploidy Dx Workflows</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 Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A53848</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:47:32.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000023929A40010738W</udiDi>
    <basicUdiDi>B-USMF000023929A40010738W</basicUdiDi>
    <tradeName>Oncomine™ Dx Express Test - Plasma - v2.1.0 ADF</tradeName>
    <deviceName>Oncomine™ Dx Express Test - Plasma - v2.1.0 ADF, a part of Ion Torrent™ Oncomine™ Dx Express Test</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A40010734</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:47:27.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000023929A40004679G</udiDi>
    <basicUdiDi>B-USMF000023929A40004679G</basicUdiDi>
    <tradeName>Oncomine™ Dx Express Test - FFPE - v2.1.0 ADF</tradeName>
    <deviceName>Oncomine™ Dx Express Test - FFPE - v2.1.0 ADF, a part of Ion Torrent™ Oncomine™ Dx Express Test</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A40004674</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:47:08.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SIGVARNZ</udiDi>
    <basicUdiDi>B-SIGVARNZ</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>SIGVAR software</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGVAR</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:29:33.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014360505</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 4M1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</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>O-DTPRIME4M1-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:14.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014362370</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 4М3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</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>O-DTPRIME4M3-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:13.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014362387</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 4М6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</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>O-DTPRIME4M6-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:11.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014362417</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 5М3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</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>O-DTPRIME5M3-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:09.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014362424</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 5М6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</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>O-DTPRIME5M6-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:47:48.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014362363</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 4Х1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</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>O-DTPRIME4Х1-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:47:47.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014362400</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 5Х1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</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>O-DTPRIME5Х1-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:47:43.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014360529</udiDi>
    <basicUdiDi>466001436DA01ZL</basicUdiDi>
    <tradeName>Real-time PCR instrument DTlite 5S1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</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>O-DTLITE5S1-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:47:28.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CN-MF-000026308-RJ001UD</udiDi>
    <basicUdiDi>B-CN-MF-000026308-RJ001UD</basicUdiDi>
    <tradeName>D-CN-MF-000026308-RJ001UD</tradeName>
    <deviceName>Human EGFR, KRAS, BRAF, NRAS, PIK3CA Gene Mutation Joint Detection Kit Analysis Software</deviceName>
    <manufacturerName>Beijing USCI Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026308</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USCI-RJ001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:09:16.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C2informHS</udiDi>
    <basicUdiDi>B-C2informHS</basicUdiDi>
    <tradeName>D-C2informHS</tradeName>
    <deviceName>C2inform</deviceName>
    <manufacturerName>Veracyte, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000048711</manufacturerSrn>
    <authorisedRepresentativeName>Veracyte Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047758</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2inform 1.0.0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:24.267Z</lastUpdated>
  </row>
</eudamedExport>