<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08059616660346</udiDi>
    <basicUdiDi>805961666ACTIONJW</basicUdiDi>
    <tradeName>ACTION</tradeName>
    <deviceName>ACTION</deviceName>
    <manufacturerName>DAS Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>OR-9711510</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:11:38.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026646530</udiDi>
    <basicUdiDi>357302BUDI002311TC</basicUdiDi>
    <tradeName>SPINCHIP® SOFTWARE</tradeName>
    <deviceName>SPINCHIP® SOFTWARE</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>425376</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:51:04.070Z</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>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>07613336201145</udiDi>
    <basicUdiDi>761333602194AT</basicUdiDi>
    <tradeName>cobas pro integrated solutions Language Pack - English Version 2.2.1 en</tradeName>
    <deviceName>cobas pro 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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09515917001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:51.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336187142</udiDi>
    <basicUdiDi>761333601994BU</basicUdiDi>
    <tradeName>cobas 8000 modular analyzer series Language Pack-English</tradeName>
    <deviceName>cobas 8000 modular analyzer series 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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09432086001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:39.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336188248</udiDi>
    <basicUdiDi>761333602155AH</basicUdiDi>
    <tradeName>cobas pure integrated solutions Instrument Software Version 01-02</tradeName>
    <deviceName>cobas pure integrated solutions Instrument Software Version 01-02</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>09458115001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:38.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336187135</udiDi>
    <basicUdiDi>761333601995BW</basicUdiDi>
    <tradeName>cobas 8000 modular analyzer series System Software Version :06-08</tradeName>
    <deviceName>cobas 8000 modular analyzer series System Software Version :06-08</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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09432078001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:20.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336183977</udiDi>
    <basicUdiDi>761333602195AV</basicUdiDi>
    <tradeName>cobas pro integrated solutions System Software Version 02-02</tradeName>
    <deviceName>cobas pro integrated solutions System Software Version 02-02</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>09400915001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:19.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336183762</udiDi>
    <basicUdiDi>761333601991BN</basicUdiDi>
    <tradeName>cobas e 411 analyzer Instrument Software Version 03-02</tradeName>
    <deviceName>cobas e 411 analyzer Instrument Software Version 03-02</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>09390090001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:18.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336181218</udiDi>
    <basicUdiDi>7613336020049T</basicUdiDi>
    <tradeName>cobas e 411 analyzer Language Pack – Italian Version 3.2.1.it</tradeName>
    <deviceName>cobas e 411 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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09309403001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:14.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260254</udiDi>
    <basicUdiDi>4049095Z999500000MW</basicUdiDi>
    <tradeName>04049095260254</tradeName>
    <deviceName>RIDA qLine® Soft</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>Z9995</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:53:08.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260636</udiDi>
    <basicUdiDi>4049095Z999500000MW</basicUdiDi>
    <tradeName>04049095260636</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>Z9995</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:40:24.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260780</udiDi>
    <basicUdiDi>4049095Z999500000MW</basicUdiDi>
    <tradeName>04049095260780</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>Z9995</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:40:21.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336181225</udiDi>
    <basicUdiDi>7613336020049T</basicUdiDi>
    <tradeName>cobas e 411 analyzer Language Pack – Japanese Version 3.2.1.ja_W10</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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09309438001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:10.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336181232</udiDi>
    <basicUdiDi>7613336020049T</basicUdiDi>
    <tradeName>cobas e 411 analyzer Language Pack – Polish Version 3.2.1.pl</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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09309446001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:10.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336181249</udiDi>
    <basicUdiDi>7613336020049T</basicUdiDi>
    <tradeName>cobas e 411 analyzer Language Pack - Russian Version 3.2.1.ru</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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09309454001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:10.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336181256</udiDi>
    <basicUdiDi>7613336020049T</basicUdiDi>
    <tradeName>cobas e 411 analyzer Language Pack – Chinese Version 3.2.1.zh_W10</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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09309462001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:10.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336181263</udiDi>
    <basicUdiDi>7613336020049T</basicUdiDi>
    <tradeName>cobas e 411 analyzer Language Pack – Czech Version 3.2.1 cs</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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09309489001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:10.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336181270</udiDi>
    <basicUdiDi>7613336020049T</basicUdiDi>
    <tradeName>cobas e 411 analyzer Language Pack – Danish Version 3.2.1 da</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>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09309497001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:10.216Z</lastUpdated>
  </row>
</eudamedExport>