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    <deviceName>Fully auto POCT chemiluminescence immunoassay analyzer</deviceName>
    <manufacturerName>Shenzhen Sinseng Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000024231</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:17:16.970Z</lastUpdated>
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    <tradeName>Automated CLEIA system</tradeName>
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    <manufacturerName>Chengdu Illumaxbio Technology Co.,LTD</manufacturerName>
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    <tradeName>Automated CLEIA system</tradeName>
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    <tradeName>Automated Electrochemiluminescence (ECL) Immunoassay Analyzer</tradeName>
    <deviceName>Automated Electrochemiluminescence (ECL) Immunoassay Analyzer</deviceName>
    <manufacturerName>Accucise Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000045017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A18111000003,A18111000004,A18111000005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:10:38.801Z</lastUpdated>
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    <udiDi>06975140162014</udiDi>
    <basicUdiDi>697509050YnY3030BJ</basicUdiDi>
    <tradeName>Automated Electrochemiluminescence (ECL) Immunoassay Analyzer</tradeName>
    <deviceName>Automated Electrochemiluminescence (ECL) Immunoassay Analyzer</deviceName>
    <manufacturerName>Accucise Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000045017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:10:38.015Z</lastUpdated>
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    <tradeName>Automatic Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Automatic Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:48:16.269Z</lastUpdated>
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    <tradeName>Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Fluorescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-05-0027</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:08:15.392Z</lastUpdated>
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    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Aikang MedTech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027272</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C 900</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:04:27.790Z</lastUpdated>
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    <udiDi>06974621212118</udiDi>
    <basicUdiDi>697462121CLIAmateGJ</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Aikang MedTech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027272</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>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLIA-mate</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:04:23.801Z</lastUpdated>
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    <udiDi>06974621212101</udiDi>
    <basicUdiDi>697462121YFA100FJ</basicUdiDi>
    <tradeName>Fluorescent Immunoanalyzer</tradeName>
    <deviceName>Fluorescent Immunoanalyzer</deviceName>
    <manufacturerName>Aikang MedTech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027272</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YFA 100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:04:23.013Z</lastUpdated>
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    <basicUdiDi>697462121URANUSAEL3</basicUdiDi>
    <tradeName>06974621211722</tradeName>
    <deviceName>Automatic Elisa Analyzer</deviceName>
    <manufacturerName>Aikang MedTech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027272</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URANUS AE 55</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:04:22.195Z</lastUpdated>
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    <udiDi>06974621211579</udiDi>
    <basicUdiDi>697462121LumimateZQ</basicUdiDi>
    <tradeName>Automated Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Automated Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Aikang MedTech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027272</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lumimate 300A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:04:14.984Z</lastUpdated>
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    <tradeName>POCLia8</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Taizhou Zecen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050486</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Chemiluminescence Immunoassay Analyzer</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:39:00.602Z</lastUpdated>
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    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T12:38:03.717Z</lastUpdated>
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    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:38:02.926Z</lastUpdated>
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    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
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    <lastUpdated>2026-07-02T12:37:58.918Z</lastUpdated>
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    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T12:37:58.110Z</lastUpdated>
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    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02</reference>
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    <lastUpdated>2026-07-02T12:37:57.323Z</lastUpdated>
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    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T12:37:56.522Z</lastUpdated>
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    <tradeName>Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Fluorescence Immunoassay Analyzer</deviceName>
    <manufacturerName>SINGUWAY BIOTECH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000027180</manufacturerSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
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    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:26:09.116Z</lastUpdated>
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