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    <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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    <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>
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    <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>04015630944064</udiDi>
    <basicUdiDi>761333602180AG</basicUdiDi>
    <tradeName>UCU for cobas 8100</tradeName>
    <deviceName>UCU 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>
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    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07476124001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:53.231Z</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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    <udiDi>04015630943920</udiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <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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    <udiDi>04015630943913</udiDi>
    <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>
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    <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>
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    <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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    <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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    <udiDi>04015630943876</udiDi>
    <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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    <udiDi>04015630943869</udiDi>
    <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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    <udiDi>04015630943838</udiDi>
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    <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>04015630943852</udiDi>
    <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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    <udiDi>04015630943845</udiDi>
    <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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    <udiDi>04015630943791</udiDi>
    <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>
    <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>07123922001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:14.732Z</lastUpdated>
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    <basicUdiDi>761333602158AP</basicUdiDi>
    <tradeName>AOB for cobas 8100</tradeName>
    <deviceName>AOB 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>07123914001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:13.932Z</lastUpdated>
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    <basicUdiDi>761333602170AD</basicUdiDi>
    <tradeName>OBS for cobas 8100</tradeName>
    <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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    <tradeName>RSF for cobas 8100</tradeName>
    <deviceName>RSF 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>07123876001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:12.346Z</lastUpdated>
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    <udiDi>06978704660001</udiDi>
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    <tradeName>06978704660001</tradeName>
    <deviceName>Mini Purifier</deviceName>
    <manufacturerName>Suzhou Acumen Biomedical Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038603</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</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>290540</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:55:37.818Z</lastUpdated>
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