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<eudamedExport entity="devices">
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    <udiDi>07613336225004</udiDi>
    <basicUdiDi>761333602977C3</basicUdiDi>
    <tradeName>cobas universal interface</tradeName>
    <deviceName>cobas universal  interface</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>9817972001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:08.862Z</lastUpdated>
  </row>
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    <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>
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    <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>
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    <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>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>
  <row>
    <udiDi>07613336202333</udiDi>
    <basicUdiDi>761333602211A2</basicUdiDi>
    <tradeName>Phadia-250 Connector to CCM (PCM2)</tradeName>
    <deviceName>Phadia-250 Connector to CCM (PCM2)</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>09511296001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:11.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202326</udiDi>
    <basicUdiDi>7613336022109Y</basicUdiDi>
    <tradeName>CCM Backend Connection Unit</tradeName>
    <deviceName>CCM Backend Connection 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>09519122001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:11.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202319</udiDi>
    <basicUdiDi>761333602209AF</basicUdiDi>
    <tradeName>CCM Address Extension Unit</tradeName>
    <deviceName>CCM Address Extension 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>09519092001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:10.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202302</udiDi>
    <basicUdiDi>761333602208AD</basicUdiDi>
    <tradeName>Linear Buffer Unit</tradeName>
    <deviceName>Linear Buffer 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>09511172001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:09.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202296</udiDi>
    <basicUdiDi>761333602207AB</basicUdiDi>
    <tradeName>Add-On Buffer Unit</tradeName>
    <deviceName>Add-On Buffer 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>09519050001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:05.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202289</udiDi>
    <basicUdiDi>761333602206A9</basicUdiDi>
    <tradeName>Power Supply Unit</tradeName>
    <deviceName>Power Supply 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>09511083001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:04.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202272</udiDi>
    <basicUdiDi>761333602205A7</basicUdiDi>
    <tradeName>Turn Unit</tradeName>
    <deviceName>Turn 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>09511113001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:03.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202265</udiDi>
    <basicUdiDi>761333602204A5</basicUdiDi>
    <tradeName>Output Unit</tradeName>
    <deviceName>Output 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>09519041001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:03.146Z</lastUpdated>
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    <udiDi>07613336202258</udiDi>
    <basicUdiDi>761333602203A3</basicUdiDi>
    <tradeName>CCM cobas c513 Connection Unit</tradeName>
    <deviceName>CCM cobas c513 Connection 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>09511393001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:59.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202241</udiDi>
    <basicUdiDi>7613336022029Z</basicUdiDi>
    <tradeName>CCM Bidirectional Unit</tradeName>
    <deviceName>CCM Bidirectional 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>09511717001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:58.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202234</udiDi>
    <basicUdiDi>7613336022019X</basicUdiDi>
    <tradeName>HST Connection Unit</tradeName>
    <deviceName>HST Connection 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>09511148001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:57.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202227</udiDi>
    <basicUdiDi>7613336022009V</basicUdiDi>
    <tradeName>cobas 8000 Connection Unit</tradeName>
    <deviceName>cobas 8000 Connection 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>09511130001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:56.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336202210</udiDi>
    <basicUdiDi>761333602199B5</basicUdiDi>
    <tradeName>cobas 6000 Connection Unit</tradeName>
    <deviceName>cobas 6000 Connection 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>09511008001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:52.724Z</lastUpdated>
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