<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07630032629127</udiDi>
    <basicUdiDi>76300326806681MY</basicUdiDi>
    <tradeName>GenoXtract fleXT</tradeName>
    <deviceName>GenoXtract fleXT</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806681</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:04.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032600027</udiDi>
    <basicUdiDi>76300326185082LS</basicUdiDi>
    <tradeName>Microlab STARlet IVD-R</tradeName>
    <deviceName>Microlab STARlet IVD-R</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>185082</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:10:59.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032600010</udiDi>
    <basicUdiDi>76300326185080LN</basicUdiDi>
    <tradeName>Microlab STAR IVD-R</tradeName>
    <deviceName>Microlab STAR IVD-R</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>185080</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:10:58.639Z</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>07613336228395</udiDi>
    <basicUdiDi>761333602961BL</basicUdiDi>
    <tradeName>Single Tube Holder (Slim)</tradeName>
    <deviceName>Single Tube Holder (Slim)</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>W02069080</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10165391001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:22.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336228388</udiDi>
    <basicUdiDi>761333602960BJ</basicUdiDi>
    <tradeName>c8100 MSC modification kit</tradeName>
    <deviceName>c8100 MSC modification kit</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>W02069080</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10165375001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:17.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336228371</udiDi>
    <basicUdiDi>761333602959BZ</basicUdiDi>
    <tradeName>RFU for cobas 8100</tradeName>
    <deviceName>RFU for cobas 8100</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>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10165367001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:16.843Z</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>07613336224274</udiDi>
    <basicUdiDi>761333602798BZ</basicUdiDi>
    <tradeName>HHT-LLD SCM retrofit kit</tradeName>
    <deviceName>HHT-LLD SCM retrofit kit</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>W02069080</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09968563001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:00.831Z</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>
</eudamedExport>