<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>80588980000174</udiDi>
    <basicUdiDi>805889800JO-TRK-0015Z</basicUdiDi>
    <tradeName>JuliaOmix TRK</tradeName>
    <deviceName>JuliaOmix TRK</deviceName>
    <manufacturerName>GenomeUp</manufacturerName>
    <manufacturerSrn>IT-MF-000046537</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRK</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:57.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>08028169207711</udiDi>
    <basicUdiDi>802816920AW02060609015C</basicUdiDi>
    <tradeName>Easy-NAT</tradeName>
    <deviceName>Easy-NAT</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9151</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:39:32.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336243343</udiDi>
    <basicUdiDi>761333603408AW</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series Language Pack - English Version 4.11.en</tradeName>
    <deviceName>cobas 8100 automated workflow series Language Pack Version 4.11</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10716142001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:03:19.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336243336</udiDi>
    <basicUdiDi>761333603407AU</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series System Software Version 04-11</tradeName>
    <deviceName>cobas 8100 automated workflow series System Software Version 04-11</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10716134001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:03:17.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336241714</udiDi>
    <basicUdiDi>761333603362AX</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series Language Pack - Spanish Version 4.10.es</tradeName>
    <deviceName>cobas 8100 automated workflow series Language Pack Version 4.10</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10652853001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:39.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336240953</udiDi>
    <basicUdiDi>761333603332AN</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series System Software Version 04-10</tradeName>
    <deviceName>cobas 8100 automated workflow series System Software Version 04-10</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10649496001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:38.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336227701</udiDi>
    <basicUdiDi>761333602930B9</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series Language Pack - English Version 4.8.en</tradeName>
    <deviceName>cobas 8100 automated workflow series Language Packs Version 4.8</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10107146001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:16.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336227695</udiDi>
    <basicUdiDi>761333602929BQ</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series System Software Version 04-08</tradeName>
    <deviceName>cobas 8100 automated workflow series System Software Version 04-08</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10106913001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:14.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336224724</udiDi>
    <basicUdiDi>761333602797BX</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series Language Pack - English Version 4.7.en</tradeName>
    <deviceName>cobas 8100 automated workflow series Language Pack Version 4.7</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09985743001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:08.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336224717</udiDi>
    <basicUdiDi>761333602796BV</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series System Software Version 04-07</tradeName>
    <deviceName>cobas 8100 automated workflow series System Software Version 04-07</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09985735001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:04.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336222058</udiDi>
    <basicUdiDi>761333602692BG</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series Language Pack - English Version 4.6.1.en</tradeName>
    <deviceName>cobas 8100 automated workflow series Language Pack Version 4.6.1</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09857044001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:56.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336222041</udiDi>
    <basicUdiDi>761333602691BE</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series System Software Version 04-06</tradeName>
    <deviceName>cobas 8100 automated workflow series System Software Version 04-06</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09857036001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:56.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336216422</udiDi>
    <basicUdiDi>761333602580B4</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series System Software Version 04-05</tradeName>
    <deviceName>cobas 8100 automated workflow series System Software Version 04-05</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09722017001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:37.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336216439</udiDi>
    <basicUdiDi>761333602581B6</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series Language Pack - English Version 4.5.1.en</tradeName>
    <deviceName>cobas 8100 automated workflow series Language Pack Version 4.5.1</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09722025001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:35.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336203415</udiDi>
    <basicUdiDi>761333602197AZ</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series Language Pack - English Version 4.4.1.en</tradeName>
    <deviceName>cobas 8100 automated workflow series Language Pack Version 4.4.1.</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09506039018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:18.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336203408</udiDi>
    <basicUdiDi>761333602196AX</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series System Software Version 04-04</tradeName>
    <deviceName>cobas 8100 automated workflow series System Software Version 04-04</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09506675001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:17.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770027563006</udiDi>
    <basicUdiDi>3770027563IVDDLCEJA</basicUdiDi>
    <tradeName>DLCE</tradeName>
    <deviceName>Dedalus LIS Calculation Engine</deviceName>
    <manufacturerName>Dedalus HealthCare France</manufacturerName>
    <manufacturerSrn>FR-MF-000025253</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLCE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:09:18.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770027563013</udiDi>
    <basicUdiDi>3770027563IVDHEXAKS</basicUdiDi>
    <tradeName>03770027563013</tradeName>
    <deviceName>Hexalis Calcul</deviceName>
    <manufacturerName>Dedalus HealthCare France</manufacturerName>
    <manufacturerSrn>FR-MF-000025253</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Hexalis Calcul</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:09:16.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336203422</udiDi>
    <basicUdiDi>761333602197AZ</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series Language Pack - German Version 4.4.1.de</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09506039003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:32:58.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336203439</udiDi>
    <basicUdiDi>761333602197AZ</basicUdiDi>
    <tradeName>cobas 8100 automated workflow series Language Pack - Spanish Version 4.4.1.es</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069082</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09506039036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:32:58.317Z</lastUpdated>
  </row>
</eudamedExport>