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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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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    <udiDi>07613336202173</udiDi>
    <basicUdiDi>761333602198B3</basicUdiDi>
    <tradeName>Conveyor 1 Unit (0,5m)</tradeName>
    <deviceName>Conveyor 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>09511024001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:51.943Z</lastUpdated>
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    <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>
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    <udiDi>07613336198391</udiDi>
    <basicUdiDi>761333601631AM</basicUdiDi>
    <tradeName>3000m Liq.Fl.Path Mod.kit e801</tradeName>
    <deviceName>3000m Liq.Fl.Path Mod.kit e801</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>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09075704001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:46.333Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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