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    <tradeName>Genexus™ Dx Strip 3-GX5™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50864 (A50431)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:50:52.997Z</lastUpdated>
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    <udiDi>10190302017534</udiDi>
    <basicUdiDi>0190302A50432RC</basicUdiDi>
    <tradeName>Genexus™ Dx Bottle 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50866 (A50432)</reference>
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    <udiDi>10190302017541</udiDi>
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    <tradeName>Genexus™ Dx Bottles 1 and 3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A50867 (A50432)</reference>
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    <deviceName>SARS-COV-2 viral RNA detection kit(real-time RT-PCR method)</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:09:59.157Z</lastUpdated>
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    <udiDi>06948500931216</udiDi>
    <basicUdiDi>69485009LBP001ML</basicUdiDi>
    <tradeName>06948500931216</tradeName>
    <deviceName>Liquid Based Cytology Reagent</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>500 tests/package</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:09:57.953Z</lastUpdated>
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    <udiDi>06948500931209</udiDi>
    <basicUdiDi>69485009LBP001ML</basicUdiDi>
    <tradeName>06948500931209</tradeName>
    <deviceName>Liquid Based Cytology Reagent</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>400 tests/package</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:09:50.754Z</lastUpdated>
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    <udiDi>06948500931193</udiDi>
    <basicUdiDi>69485009LBP001ML</basicUdiDi>
    <tradeName>06948500931193</tradeName>
    <deviceName>Liquid Based Cytology Reagent</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>300 tests/package</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:09:49.557Z</lastUpdated>
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    <udiDi>06948500931186</udiDi>
    <basicUdiDi>69485009LBP001ML</basicUdiDi>
    <tradeName>06948500931186</tradeName>
    <deviceName>Liquid Based Cytology Reagent</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>200 tests/package</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:09:48.348Z</lastUpdated>
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    <udiDi>06948500931179</udiDi>
    <basicUdiDi>69485009LBP001ML</basicUdiDi>
    <tradeName>06948500931179</tradeName>
    <deviceName>Liquid Based Cytology Reagent</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>100 tests/package</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:09:47.145Z</lastUpdated>
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    <udiDi>06948500931162</udiDi>
    <basicUdiDi>69485009LBP001ML</basicUdiDi>
    <tradeName>06948500931162</tradeName>
    <deviceName>Liquid Based Cytology Reagent</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>24 tests/package</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:09:41.142Z</lastUpdated>
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    <udiDi>06948500931155</udiDi>
    <basicUdiDi>69485009LBP001ML</basicUdiDi>
    <tradeName>06948500931155</tradeName>
    <deviceName>Liquid Based Cytology Reagent</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>12 tests/package</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:09:39.943Z</lastUpdated>
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    <udiDi>06948500931117</udiDi>
    <basicUdiDi>B-06948500931117</basicUdiDi>
    <tradeName>06948500931117</tradeName>
    <deviceName>Human Papillomavirus Gene Test Kit (PCR-Fluorescence)</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:09:30.550Z</lastUpdated>
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    <udiDi>08720299808775</udiDi>
    <basicUdiDi>87202998087CBT7F</basicUdiDi>
    <tradeName>Clean Blood &amp; Tissue DNA Kit Dx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CleanNA B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000022870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBTDx-D0096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:58:02.511Z</lastUpdated>
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    <udiDi>06937044501054</udiDi>
    <basicUdiDi>B-06937044501054</basicUdiDi>
    <tradeName>06937044501054</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA19043</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:52:03.163Z</lastUpdated>
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    <udiDi>06937044501047</udiDi>
    <basicUdiDi>B-06937044501047</basicUdiDi>
    <tradeName>06937044501047</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GY07083</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:52:00.861Z</lastUpdated>
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    <udiDi>06937044501030</udiDi>
    <basicUdiDi>B-06937044501030</basicUdiDi>
    <tradeName>06937044501030</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA15053</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:58.342Z</lastUpdated>
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    <udiDi>06937044501023</udiDi>
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    <tradeName>06937044501023</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GY08073</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:57.140Z</lastUpdated>
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    <tradeName>06937044501016</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA08117</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:55.943Z</lastUpdated>
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    <tradeName>06937044501009</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1040026</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:54.742Z</lastUpdated>
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    <tradeName>06937044500996</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA13033</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:52.340Z</lastUpdated>
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