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    <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>
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    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
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    <reference>07649142001</reference>
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    <lastUpdated>2026-07-03T02:57:57.230Z</lastUpdated>
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    <tradeName>UCU for cobas 8100</tradeName>
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    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
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    <reference>07476124001</reference>
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    <basicUdiDi>761333602184AQ</basicUdiDi>
    <tradeName>Connection kit STA-R</tradeName>
    <deviceName>Connection kit STA-R</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
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    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>761333602186AU</basicUdiDi>
    <tradeName>Signal Tower</tradeName>
    <deviceName>Signal Tower</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>07474652001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:51.634Z</lastUpdated>
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    <udiDi>04015630944033</udiDi>
    <basicUdiDi>761333602181AJ</basicUdiDi>
    <tradeName>URF for cobas 8100</tradeName>
    <deviceName>URF 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>07441657001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:50.831Z</lastUpdated>
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    <udiDi>04015630943937</udiDi>
    <basicUdiDi>761333602179AX</basicUdiDi>
    <tradeName>TLJ300 for cobas 8100</tradeName>
    <deviceName>TLJ 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>07440103001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:46.824Z</lastUpdated>
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    <basicUdiDi>761333602178AV</basicUdiDi>
    <tradeName>SLR for cobas 8100</tradeName>
    <deviceName>SLR for cobas 8100</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>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07440090001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:46.029Z</lastUpdated>
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    <basicUdiDi>761333602177AT</basicUdiDi>
    <tradeName>SLL for cobas 8100</tradeName>
    <deviceName>SLL 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>07440081001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:45.234Z</lastUpdated>
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    <basicUdiDi>761333602176AR</basicUdiDi>
    <tradeName>SCM for cobas 8100</tradeName>
    <deviceName>SCM 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>07440073001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:44.428Z</lastUpdated>
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    <udiDi>04015630943890</udiDi>
    <basicUdiDi>761333602173AK</basicUdiDi>
    <tradeName>RFX for cobas 8100</tradeName>
    <deviceName>RFX 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>07440065001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:40.421Z</lastUpdated>
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    <udiDi>04015630943883</udiDi>
    <basicUdiDi>761333602171AF</basicUdiDi>
    <tradeName>PXT for cobas 8100</tradeName>
    <deviceName>PXT 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>07440057001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:39.622Z</lastUpdated>
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    <basicUdiDi>761333602166AN</basicUdiDi>
    <tradeName>CRW for cobas 8100</tradeName>
    <deviceName>CRW 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>07440049001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:38.823Z</lastUpdated>
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    <basicUdiDi>761333602165AL</basicUdiDi>
    <tradeName>CRO for cobas 8100</tradeName>
    <deviceName>CRO 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>07440022001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:38.031Z</lastUpdated>
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    <basicUdiDi>761333602162AE</basicUdiDi>
    <tradeName>BRF for cobas 8100</tradeName>
    <deviceName>BRF 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>07439954001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:34.055Z</lastUpdated>
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    <udiDi>04015630943807</udiDi>
    <basicUdiDi>761333602183AN</basicUdiDi>
    <tradeName>BCL Screw Top Tube Modification Kit</tradeName>
    <deviceName>BCL Screw Top Tube 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>07123957001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:33.204Z</lastUpdated>
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    <basicUdiDi>761333602164AJ</basicUdiDi>
    <tradeName>CLW for cobas 8100</tradeName>
    <deviceName>CLW 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>07440006001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:32.436Z</lastUpdated>
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    <basicUdiDi>761333602163AG</basicUdiDi>
    <tradeName>CLO for cobas 8100</tradeName>
    <deviceName>CLO 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>07439997001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:31.741Z</lastUpdated>
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    <basicUdiDi>761333602160AA</basicUdiDi>
    <tradeName>BCL for cobas 8100</tradeName>
    <deviceName>BCL for cobas 8100</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07123922001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:14.732Z</lastUpdated>
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    <deviceName>AOB for cobas 8100</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07123914001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:13.932Z</lastUpdated>
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    <basicUdiDi>761333602170AD</basicUdiDi>
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    <deviceName>OBS for cobas 8100</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>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07123892001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:13.170Z</lastUpdated>
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