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    <deviceName>Fully Automated Nucleic Acid Extractor</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>（01）6973609150183（11）210105（21）5B92021001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:11.232Z</lastUpdated>
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    <deviceName>Fully Automated CLIA Workstation</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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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>AB pazarı için değil</deviceStatus>
    <reference>（01）6973609150176（11）210112（21）5A92021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:10.424Z</lastUpdated>
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    <deviceName>Automated Liquid Handling System</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>（01）6973609150114（11）210830（21）5112021001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:09.625Z</lastUpdated>
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    <deviceName>Fully Automated ELISA Workstation</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</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>（01）6973609150107（11）210111（21）5102021001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:08.832Z</lastUpdated>
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    <udiDi>06973609150091</udiDi>
    <basicUdiDi>697360915009KQ</basicUdiDi>
    <tradeName>06973609150091</tradeName>
    <deviceName>Fully Automated ELISA Workstation</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</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>（01）6973609150091（11）210105（21）5092021001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:05.093Z</lastUpdated>
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    <udiDi>06973609150077</udiDi>
    <basicUdiDi>697360915007KL</basicUdiDi>
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    <deviceName>Fully Automated ELISA Workstation</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</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>（01）6973609150077（11）210104（21）5072021001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:04.017Z</lastUpdated>
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    <basicUdiDi>697360915005KG</basicUdiDi>
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    <deviceName>Fully Automated ELISA Workstation</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>（01）6973609150053（11）210108（21）5052021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:03.236Z</lastUpdated>
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    <basicUdiDi>697360915002KA</basicUdiDi>
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    <deviceName>Fully Automated ELISA Workstation</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:02.420Z</lastUpdated>
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    <udiDi>16973609154997</udiDi>
    <basicUdiDi>697360915499M7</basicUdiDi>
    <tradeName>16973609154997</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:16:03.707Z</lastUpdated>
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    <udiDi>16973609155000</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:16:03.689Z</lastUpdated>
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    <udiDi>16973609155024</udiDi>
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    <tradeName>16973609155024</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:16:03.669Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>Z1399</emdnCode>
    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:16:03.647Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <emdnDescription>NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:16:03.630Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:16:03.615Z</lastUpdated>
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    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:16:03.601Z</lastUpdated>
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