<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>07613336220610</udiDi>
    <basicUdiDi>761333602670B6</basicUdiDi>
    <tradeName>cobas pro A-Gate Upgrade Kit</tradeName>
    <deviceName>cobas pro A-Gate Upgrade 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>W0201010180</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09813799001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:55.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336220207</udiDi>
    <basicUdiDi>761333602786BS</basicUdiDi>
    <tradeName>Reaction Cell for c 703</tradeName>
    <deviceName>Reaction Cell for c 703</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>W0201010180</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09796762001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:54.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336218525</udiDi>
    <basicUdiDi>761333602635B4</basicUdiDi>
    <tradeName>cobas pure integrated solutions Language Pack - English Version 1.3.1.en</tradeName>
    <deviceName>cobas pure integrated solutions Language Pack Version 1.3.1</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09756817001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:50.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336218518</udiDi>
    <basicUdiDi>761333602640AV</basicUdiDi>
    <tradeName>cobas pure integrated solutions System Software Version 01-03</tradeName>
    <deviceName>cobas pure integrated solutions System Software Version 01-03</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09756809001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:49.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336218242</udiDi>
    <basicUdiDi>761333602664BB</basicUdiDi>
    <tradeName>CCM Vertical Power Box Unit</tradeName>
    <deviceName>CCM Vertical Power Box Unit</deviceName>
    <manufacturerName>Hitachi, Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000018582</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09751513001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:48.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336218235</udiDi>
    <basicUdiDi>761333602663B9</basicUdiDi>
    <tradeName>CCM Vertical Turntable Unit</tradeName>
    <deviceName>CCM Vertical Turntable Unit</deviceName>
    <manufacturerName>Hitachi, Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000018582</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09751505001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:48.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336218228</udiDi>
    <basicUdiDi>761333602662B7</basicUdiDi>
    <tradeName>CCM Vertical Overhead Conveyor Unit (1.0m)</tradeName>
    <deviceName>CCM Vertical Overhead Conveyor Unit (1.0m)</deviceName>
    <manufacturerName>Hitachi, Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000018582</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09751491001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:44.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336218211</udiDi>
    <basicUdiDi>761333602661B5</basicUdiDi>
    <tradeName>CCM Vertical Elevator Unit</tradeName>
    <deviceName>CCM Vertical Elevator Unit</deviceName>
    <manufacturerName>Hitachi, Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000018582</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09751483001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:43.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336217900</udiDi>
    <basicUdiDi>761333602639BC</basicUdiDi>
    <tradeName>cobas pro integrated solutions System Software Version 02-03</tradeName>
    <deviceName>cobas pro integrated solutions System Software Version 02-03</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09719385001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:42.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336217788</udiDi>
    <basicUdiDi>761333602637B8</basicUdiDi>
    <tradeName>cobas pro integrated solutions Language Pack - English Version 2.3.1.en</tradeName>
    <deviceName>cobas pro integrated solutions Language Pack Version 2.3.1</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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09717862001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:41.617Z</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>07613336215852</udiDi>
    <basicUdiDi>761333602638BA</basicUdiDi>
    <tradeName>cobas 8000 modular analyzer series Language Pack - Chinese Version 6.9.1.zh</tradeName>
    <deviceName>cobas 8000 modular analyzer series Language Pack Version 6.9.1</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09720073001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:36.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336217375</udiDi>
    <basicUdiDi>761333602508AU</basicUdiDi>
    <tradeName>cobas 8000 modular analyzer series System Software Version 06-09</tradeName>
    <deviceName>cobas 8000 modular analyzer series System Software Version 06-09</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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09712097001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:36.061Z</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>07613336202432</udiDi>
    <basicUdiDi>761333602213A6</basicUdiDi>
    <tradeName>Phadia-250 Connector to cobas 8100 (PCM1)</tradeName>
    <deviceName>Phadia-250 Connector to cobas 8100 (PCM1)</deviceName>
    <manufacturerName>Hitachi, Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000018582</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09527214001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:16.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202340</udiDi>
    <basicUdiDi>761333602212A4</basicUdiDi>
    <tradeName>LIAISON® XL Connection Module for CCM (LCM2)</tradeName>
    <deviceName>LIAISON® XL Connection Module for CCM (LCM2)</deviceName>
    <manufacturerName>Hitachi, Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000018582</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09511385001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:15.945Z</lastUpdated>
  </row>
</eudamedExport>