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<eudamedExport entity="devices">
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    <basicUdiDi>69503348MTA001LH</basicUdiDi>
    <tradeName>Auto Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Auto Chemiluminescence Immunoassay 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>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MT60S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:44:15.961Z</lastUpdated>
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    <udiDi>06950334821465</udiDi>
    <basicUdiDi>69503348MTA001LH</basicUdiDi>
    <tradeName>Auto Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Auto Chemiluminescence Immunoassay 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>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MT60</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:44:15.055Z</lastUpdated>
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    <udiDi>06950334819486</udiDi>
    <basicUdiDi>69503348PAA005FF</basicUdiDi>
    <tradeName>Fully-auto Specific Protein Analyzer</tradeName>
    <deviceName>Fully-auto Specific Protein 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>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA480</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:42:32.895Z</lastUpdated>
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    <udiDi>06950334819479</udiDi>
    <basicUdiDi>69503348PAA005FF</basicUdiDi>
    <tradeName>06950334819479</tradeName>
    <deviceName>Fully-auto Specific Protein 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>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA240</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:42:30.858Z</lastUpdated>
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  <row>
    <udiDi>06950334818434</udiDi>
    <basicUdiDi>69503348MTA002LK</basicUdiDi>
    <tradeName>06950334818434</tradeName>
    <deviceName>Handheld Dry Fluorescence Immunoassay 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>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:42:29.337Z</lastUpdated>
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  <row>
    <udiDi>06950334818168</udiDi>
    <basicUdiDi>69503348FAA002B7</basicUdiDi>
    <tradeName>Quantitative lmmunoassay Analyzer</tradeName>
    <deviceName>Quantitative lmmunoassay 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>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA30</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:42:27.025Z</lastUpdated>
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    <udiDi>06950334804444</udiDi>
    <basicUdiDi>69503348FAA001B5</basicUdiDi>
    <tradeName>Quantitative lmmunoassay Analyzer</tradeName>
    <deviceName>Quantitative lmmunoassay 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>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:40:10.032Z</lastUpdated>
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  <row>
    <udiDi>06950334803300</udiDi>
    <basicUdiDi>69503348PAA001F7</basicUdiDi>
    <tradeName>Specific Protein Analyzer</tradeName>
    <deviceName>Specific Protein 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>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA50</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:39:20.864Z</lastUpdated>
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  <row>
    <udiDi>06950334800965</udiDi>
    <basicUdiDi>69503348PAA002F9</basicUdiDi>
    <tradeName>Fully-auto Specific Protein Analyzer</tradeName>
    <deviceName>Fully-auto Specific Protein 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>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA120</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:37:03.203Z</lastUpdated>
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    <udiDi>06950334800019</udiDi>
    <basicUdiDi>69503348PAA001F7</basicUdiDi>
    <tradeName>Specific Protein Analyzer</tradeName>
    <deviceName>Specific Protein 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>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA54</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:36:49.754Z</lastUpdated>
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    <udiDi>06948500937560</udiDi>
    <basicUdiDi>69485009IHC001KL</basicUdiDi>
    <tradeName>06948500937560</tradeName>
    <deviceName>Fully Automated IHC &amp; ISH Staining System</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>198-242V：CCP.000145-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:11:59.214Z</lastUpdated>
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    <udiDi>06948500936730</udiDi>
    <basicUdiDi>69485009IHC001KL</basicUdiDi>
    <tradeName>06948500936730</tradeName>
    <deviceName>Fully Automated IHC &amp; ISH Staining System</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCP.000133</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:10:42.377Z</lastUpdated>
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    <udiDi>06926980315375</udiDi>
    <basicUdiDi>69269803YQHiLIA1250i3F</basicUdiDi>
    <tradeName>HiLIA 1251i</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-KR-BLOT-006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:11:32.887Z</lastUpdated>
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    <udiDi>06926980315382</udiDi>
    <basicUdiDi>69269803YQHiLIA1250i3F</basicUdiDi>
    <tradeName>HiLIA 1252i</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-KR-BLOT-007</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:11:32.851Z</lastUpdated>
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    <udiDi>06926980316907</udiDi>
    <basicUdiDi>69269803YQKaeser2000UX</basicUdiDi>
    <tradeName>06926980316907</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-KR-CLIA-002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T23:11:32.616Z</lastUpdated>
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    <udiDi>06947145528782</udiDi>
    <basicUdiDi>69471455X6GB</basicUdiDi>
    <tradeName>MAGLUMI X6</tradeName>
    <deviceName>MAGLUMI X6</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>010101006601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:19:49.480Z</lastUpdated>
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    <udiDi>06947145513597</udiDi>
    <basicUdiDi>69471455Preaccu6W</basicUdiDi>
    <tradeName>Preaccu</tradeName>
    <deviceName>Preaccu for Prenatal Screening</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22010315</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:19:01.895Z</lastUpdated>
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    <udiDi>06947145513481</udiDi>
    <basicUdiDi>69471455X3G5</basicUdiDi>
    <tradeName>MAGLUMI X3</tradeName>
    <deviceName>MAGLUMI X3</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010101003301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:19:00.442Z</lastUpdated>
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    <udiDi>06947145513467</udiDi>
    <basicUdiDi>69471455X8GF</basicUdiDi>
    <tradeName>MAGLUMI X8</tradeName>
    <deviceName>MAGLUMI X8</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>010101008801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:18:59.547Z</lastUpdated>
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    <basicUdiDi>69471455M800QH</basicUdiDi>
    <tradeName>MAGLUMI 800</tradeName>
    <deviceName>MAGLUMI 800</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23020003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:18:57.842Z</lastUpdated>
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