<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07613336188644</udiDi>
    <basicUdiDi>761333601996BY</basicUdiDi>
    <tradeName>cobas c 311 analyzer Instrument Software Version 01-13</tradeName>
    <deviceName>cobas c 311 analyzer Instrument Software Version 01-13</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>09465596001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:45.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336188583</udiDi>
    <basicUdiDi>761333601997C2</basicUdiDi>
    <tradeName>cobas c 311 analyzer Language Pack 1.13.1.pt</tradeName>
    <deviceName>cobas c 311 analyzer Language Pack</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>09465537001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:44.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336188262</udiDi>
    <basicUdiDi>761333602146AG</basicUdiDi>
    <tradeName>cobas pure integrated solutions Language Pack - German Version 01-02</tradeName>
    <deviceName>cobas pure integrated solutions Language Pack</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>09458620001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:43.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336187722</udiDi>
    <basicUdiDi>761333602149AN</basicUdiDi>
    <tradeName>cobas c 513 analyzer System software installation CD Version 02-05</tradeName>
    <deviceName>cobas c 513 analyzer System software installation CD Version 02-05</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09440194001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:39.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336187739</udiDi>
    <basicUdiDi>761333602156AK</basicUdiDi>
    <tradeName>cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;5;1</tradeName>
    <deviceName>cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09440208001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:37.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336172605</udiDi>
    <basicUdiDi>761333601775BE</basicUdiDi>
    <tradeName>Reaction Cell c 303</tradeName>
    <deviceName>Reaction Cell c 303</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>09033408001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:59.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336172483</udiDi>
    <basicUdiDi>761333601771B6</basicUdiDi>
    <tradeName>cobas c 303 analytical unit</tradeName>
    <deviceName>cobas c 303 analytical unit</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>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09031529001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:53.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336158876</udiDi>
    <basicUdiDi>761333601581AX</basicUdiDi>
    <tradeName>cobas pro ISE analytical unit</tradeName>
    <deviceName>cobas pro ISE analytical unit</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>W0201010107</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08464537001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:42.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336158784</udiDi>
    <basicUdiDi>761333601576B6</basicUdiDi>
    <tradeName>cobas c 503 analytical unit</tradeName>
    <deviceName>cobas c 503 analytical unit</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>W0201010107</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08463662001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:41.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336156773</udiDi>
    <basicUdiDi>761333601511AA</basicUdiDi>
    <tradeName>Reaction Cell c 503 / c 513</tradeName>
    <deviceName>Reaction Cell c 503 / c 513</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>07700814001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:39.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336153987</udiDi>
    <basicUdiDi>761333601546AV</basicUdiDi>
    <tradeName>B-gate connection kit for cobas c 513 analyzer</tradeName>
    <deviceName>B-gate connection kit for cobas c 513 analyzer</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>08341621001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:34.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630946341</udiDi>
    <basicUdiDi>761333601394AW</basicUdiDi>
    <tradeName>cobas 8000 ISE 1800 Module</tradeName>
    <deviceName>cobas 8000 ISE 1800 Module</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>W0201010108</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05964075001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:58.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630946327</udiDi>
    <basicUdiDi>761333601501A7</basicUdiDi>
    <tradeName>cobas c 513 analyzer</tradeName>
    <deviceName>cobas c 513 analyzer</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>W0201010102</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07649142001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:57.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630934263</udiDi>
    <basicUdiDi>761333601280AE</basicUdiDi>
    <tradeName>Reaction Cell c 311</tradeName>
    <deviceName>Reaction Cell c 311</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>04555040001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:48.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630930845</udiDi>
    <basicUdiDi>761333601421A8</basicUdiDi>
    <tradeName>cobas 8000 c 702 Module</tradeName>
    <deviceName>cobas 8000 c 702 Module</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>W0201010108</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06473245001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:47.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630928347</udiDi>
    <basicUdiDi>761333601372AL</basicUdiDi>
    <tradeName>cobas 8000 ISE 900 Module</tradeName>
    <deviceName>cobas 8000 ISE 900 Module</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>W0201010108</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05641497001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:46.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630928255</udiDi>
    <basicUdiDi>761333601371AJ</basicUdiDi>
    <tradeName>cobas 8000 c 701 Module</tradeName>
    <deviceName>cobas 8000 c 701 Module</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>W0201010108</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05641489001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:41.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630927289</udiDi>
    <basicUdiDi>761333601343AD</basicUdiDi>
    <tradeName>Reaction Cell c 701 / c 702</tradeName>
    <deviceName>Reaction Cell c 701 / c 702</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>04939719001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:41.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630925551</udiDi>
    <basicUdiDi>761333601323A7</basicUdiDi>
    <tradeName>cobas c 311 analyzer</tradeName>
    <deviceName>cobas c 311 analyzer</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>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04826876001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:40.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630924110</udiDi>
    <basicUdiDi>761333601327AF</basicUdiDi>
    <tradeName>Reaction Cell c 501 / c 502</tradeName>
    <deviceName>Reaction Cell c 501 / c 502</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>04854241001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:34.731Z</lastUpdated>
  </row>
</eudamedExport>