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    <tradeName>06950334803102</tradeName>
    <deviceName>PVC Electrode Activating Solution</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42005002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:39:06.443Z</lastUpdated>
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    <udiDi>06950334803096</udiDi>
    <basicUdiDi>69503348GEA002CY</basicUdiDi>
    <tradeName>Cleaning solution</tradeName>
    <deviceName>Cleaning solution</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:39:04.059Z</lastUpdated>
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    <tradeName>Deproteinizer</tradeName>
    <deviceName>Deproteinizer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:39:03.173Z</lastUpdated>
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    <udiDi>06950334803065</udiDi>
    <basicUdiDi>69503348GEA005D6</basicUdiDi>
    <tradeName>06950334803065</tradeName>
    <deviceName>DS-ISE ISE Filling Solution</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070302</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42045001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:39:00.404Z</lastUpdated>
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    <udiDi>06950334803058</udiDi>
    <basicUdiDi>69503348GEA006D8</basicUdiDi>
    <tradeName>06950334803058</tradeName>
    <deviceName>DS-Ref Ref. Filling Solution</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070302</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42046001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:55.599Z</lastUpdated>
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    <udiDi>06950334803041</udiDi>
    <basicUdiDi>B-06950334803041</basicUdiDi>
    <tradeName>06950334803041</tradeName>
    <deviceName>QC Solution</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42005004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:53.208Z</lastUpdated>
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    <udiDi>06950334803034</udiDi>
    <basicUdiDi>B-06950334803034</basicUdiDi>
    <tradeName>06950334803034</tradeName>
    <deviceName>Quality Control Solution (QC Solution)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42082006</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:51.989Z</lastUpdated>
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    <udiDi>06950334803003</udiDi>
    <basicUdiDi>69503348GSA001HQ</basicUdiDi>
    <tradeName>Auto Chemistry Analyzer</tradeName>
    <deviceName>Auto Chemistry Analyzer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS480A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:49.609Z</lastUpdated>
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    <udiDi>06950334802990</udiDi>
    <basicUdiDi>69503348GSA001HQ</basicUdiDi>
    <tradeName>Auto Chemistry Analyzer</tradeName>
    <deviceName>Auto Chemistry Analyzer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS300Plus</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:45.997Z</lastUpdated>
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    <udiDi>06950334802976</udiDi>
    <basicUdiDi>69503348WPA001P7</basicUdiDi>
    <tradeName>06950334802976</tradeName>
    <deviceName>Semi-auto Chemistry Analyzer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010299</emdnCode>
    <emdnDescription>LIMITED PANEL CHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WP21E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:43.579Z</lastUpdated>
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    <udiDi>06950334802969</udiDi>
    <basicUdiDi>69503348WPA001P7</basicUdiDi>
    <tradeName>06950334802969</tradeName>
    <deviceName>Semi-auto Chemistry Analyzer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010299</emdnCode>
    <emdnDescription>LIMITED PANEL CHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WP21B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:42.595Z</lastUpdated>
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    <udiDi>06950334802945</udiDi>
    <basicUdiDi>69503348CAA0019W</basicUdiDi>
    <tradeName>Coagulation Analyzer</tradeName>
    <deviceName>Coagulation Analyzer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA51</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:38.787Z</lastUpdated>
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    <udiDi>06950334802907</udiDi>
    <basicUdiDi>69503348KTA009L7</basicUdiDi>
    <tradeName>KT05A LH Lyse</tradeName>
    <deviceName>KT05/KT05A LH Lyse</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22013010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:35.183Z</lastUpdated>
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    <udiDi>06950334802846</udiDi>
    <basicUdiDi>69503348KTA008L5</basicUdiDi>
    <tradeName>KT05A DIL Diluent</tradeName>
    <deviceName>KT05A DIL Diluent</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22024019</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:33.298Z</lastUpdated>
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    <udiDi>06950334802808</udiDi>
    <basicUdiDi>69503348KTA006KZ</basicUdiDi>
    <tradeName>Probe Cleanser</tradeName>
    <deviceName>Probe Cleanser</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>22008009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:31.576Z</lastUpdated>
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    <udiDi>06950334802792</udiDi>
    <basicUdiDi>69503348KTA006KZ</basicUdiDi>
    <tradeName>Probe Cleanser</tradeName>
    <deviceName>Probe Cleanser</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
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    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22005009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:29.171Z</lastUpdated>
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    <basicUdiDi>69503348KTA006KZ</basicUdiDi>
    <tradeName>Probe Cleanser</tradeName>
    <deviceName>Probe Cleanser</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22003009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:24.392Z</lastUpdated>
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    <basicUdiDi>69503348KTA007L3</basicUdiDi>
    <tradeName>KT05 DIFF Lyse</tradeName>
    <deviceName>KT05/KT05A DIFF Lyse</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23019007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:21.988Z</lastUpdated>
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    <tradeName>KT03A Lyse Solution</tradeName>
    <deviceName>KT03/KT03A Lyse Solution</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22019017</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:20.785Z</lastUpdated>
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    <basicUdiDi>69503348KTA001KP</basicUdiDi>
    <tradeName>KT03A Diluent</tradeName>
    <deviceName>KT03/KT03A Diluent</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22024018</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:38:18.389Z</lastUpdated>
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