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    <tradeName>Laser BCR modification kit for BRF</tradeName>
    <deviceName>Laser BCR modification 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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>08433020001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:52.631Z</lastUpdated>
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    <udiDi>07613336164853</udiDi>
    <basicUdiDi>761333601610AD</basicUdiDi>
    <tradeName>cobas pro liquid waste container</tradeName>
    <deviceName>cobas pro liquid waste container</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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>08763704001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:48.630Z</lastUpdated>
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    <udiDi>07613336164846</udiDi>
    <basicUdiDi>761333601609AU</basicUdiDi>
    <tradeName>cobas pro B-Gate update kit</tradeName>
    <deviceName>cobas pro B-Gate update 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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>08763640001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:47.844Z</lastUpdated>
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    <udiDi>07613336164525</udiDi>
    <basicUdiDi>761333601519AS</basicUdiDi>
    <tradeName>cobas 8000 A-Gate Connection KIT</tradeName>
    <deviceName>cobas 8000 A-Gate Connection 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>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07996527 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:47.024Z</lastUpdated>
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    <udiDi>07613336160992</udiDi>
    <basicUdiDi>761333601413A9</basicUdiDi>
    <tradeName>cobas 8000 B-Gate KIT</tradeName>
    <deviceName>cobas 8000 B-Gate 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>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06372546001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:46.248Z</lastUpdated>
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    <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>
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    <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>
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    <udiDi>07613336158562</udiDi>
    <basicUdiDi>761333601562AT</basicUdiDi>
    <tradeName>cobas e 801 MSB/MSBL</tradeName>
    <deviceName>cobas e 801 MSB/MSBL</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>W0201020103</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput &gt; 250 and &lt;= 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08459606 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:40.644Z</lastUpdated>
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    <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>
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    <udiDi>07613336146934</udiDi>
    <basicUdiDi>761333602188AY</basicUdiDi>
    <tradeName>c8100 HHT/Sysmex TrayLane Arm cover</tradeName>
    <deviceName>c8100 HHT/Sysmex TrayLane Arm cover</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>W02069080</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08137218001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:35.815Z</lastUpdated>
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    <udiDi>07613336146903</udiDi>
    <basicUdiDi>761333602187AW</basicUdiDi>
    <tradeName>c8100 HHT 1 tray IPB/OBS mod kit</tradeName>
    <deviceName>c8100 HHT 1 tray IPB/OBS mod 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>W02069080</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08137536001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:35.019Z</lastUpdated>
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    <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>
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    <udiDi>07613336148235</udiDi>
    <basicUdiDi>761333602185AS</basicUdiDi>
    <tradeName>cobas 6500 URF Modification Kit</tradeName>
    <deviceName>cobas 6500 URF Modification 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>W02069080</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08260125001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:33.534Z</lastUpdated>
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    <udiDi>07613336142561</udiDi>
    <basicUdiDi>761333602161AC</basicUdiDi>
    <tradeName>2nd BCL for cobas 8100</tradeName>
    <deviceName>2nd BCL for cobas 8100</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>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08010595001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:16.553Z</lastUpdated>
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    <udiDi>07613336142554</udiDi>
    <basicUdiDi>761333602169AU</basicUdiDi>
    <tradeName>2nd IPB for cobas 8100</tradeName>
    <deviceName>2nd IPB for cobas 8100</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>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08015597001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:15.747Z</lastUpdated>
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    <udiDi>07613336142547</udiDi>
    <basicUdiDi>761333602175AP</basicUdiDi>
    <tradeName>RSS for cobas 8100</tradeName>
    <deviceName>RSS for cobas 8100</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>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08015589001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:14.966Z</lastUpdated>
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    <udiDi>07613336101537</udiDi>
    <basicUdiDi>761333602167AQ</basicUdiDi>
    <tradeName>DSP for cobas 8100</tradeName>
    <deviceName>DSP for cobas 8100</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>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07787146001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:14.160Z</lastUpdated>
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    <udiDi>07613336101254</udiDi>
    <basicUdiDi>761333602159AR</basicUdiDi>
    <tradeName>AQM for cobas 8100</tradeName>
    <deviceName>AQM for cobas 8100</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>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07787138001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:10.159Z</lastUpdated>
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    <udiDi>07613336101247</udiDi>
    <basicUdiDi>761333602168AS</basicUdiDi>
    <tradeName>IPB for cobas 8100</tradeName>
    <deviceName>IPB for cobas 8100</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>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07787120001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:09.345Z</lastUpdated>
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    <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>
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