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    <tradeName>ADV Antigen Rapid Test Device</tradeName>
    <deviceName>ADV Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P212113</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:55.437Z</lastUpdated>
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    <udiDi>16972698600200</udiDi>
    <basicUdiDi>B-16972698600200</basicUdiDi>
    <tradeName>TB MPT64</tradeName>
    <deviceName>TB MPT64</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P211010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:50.631Z</lastUpdated>
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    <udiDi>16972698600194</udiDi>
    <basicUdiDi>B-16972698600194</basicUdiDi>
    <tradeName>H.pylori Antigen Rapid Test</tradeName>
    <deviceName>H.pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:49.842Z</lastUpdated>
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    <udiDi>16972698600149</udiDi>
    <basicUdiDi>B-16972698600149</basicUdiDi>
    <tradeName>Norovirus Antigen Rapid Test Device</tradeName>
    <deviceName>Norovirus Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:45.025Z</lastUpdated>
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    <udiDi>16972698600125</udiDi>
    <basicUdiDi>B-16972698600125</basicUdiDi>
    <tradeName>Strep. pneumoniae Antigen Rapid Test</tradeName>
    <deviceName>Strep. pneumoniae Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P241108</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:25.770Z</lastUpdated>
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    <udiDi>16972698600095</udiDi>
    <basicUdiDi>B-16972698600095</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae Antigen Rapid Test</tradeName>
    <deviceName>Mycoplasma pneumoniae Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P211006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:23.374Z</lastUpdated>
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    <udiDi>16972698600040</udiDi>
    <basicUdiDi>B-16972698600040</basicUdiDi>
    <tradeName>Respiratory Syncytial Virus Antigen Rapid Test</tradeName>
    <deviceName>Respiratory Syncytial Virus Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P211004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:18.575Z</lastUpdated>
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    <udiDi>16972698600033</udiDi>
    <basicUdiDi>B-16972698600033</basicUdiDi>
    <tradeName>Adenovirus Antigen Rapid Test</tradeName>
    <deviceName>Adenovirus Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P211005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:17.774Z</lastUpdated>
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    <udiDi>16972698600019</udiDi>
    <basicUdiDi>B-16972698600019</basicUdiDi>
    <tradeName>TB MPT64</tradeName>
    <deviceName>TB MPT64</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P211009</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:12.966Z</lastUpdated>
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    <udiDi>16971760720112</udiDi>
    <basicUdiDi>B-16971760720112</basicUdiDi>
    <tradeName>16971760720112</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Qualitative Test</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:29:59.334Z</lastUpdated>
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    <udiDi>16971760720105</udiDi>
    <basicUdiDi>B-16971760720105</basicUdiDi>
    <tradeName>16971760720105</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Qualitative Test</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:29:58.537Z</lastUpdated>
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    <udiDi>16971760720099</udiDi>
    <basicUdiDi>B-16971760720099</basicUdiDi>
    <tradeName>16971760720099</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Qualitative Test</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:29:57.734Z</lastUpdated>
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    <udiDi>16971760720082</udiDi>
    <basicUdiDi>B-16971760720082</basicUdiDi>
    <tradeName>16971760720082</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Qualitative Test</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:29:53.734Z</lastUpdated>
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    <udiDi>16971760720075</udiDi>
    <basicUdiDi>B-16971760720075</basicUdiDi>
    <tradeName>16971760720075</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Qualitative Test</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:29:52.932Z</lastUpdated>
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    <udiDi>16971760720068</udiDi>
    <basicUdiDi>B-16971760720068</basicUdiDi>
    <tradeName>16971760720068</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Qualitative Test</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:29:52.129Z</lastUpdated>
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    <udiDi>16955792730738</udiDi>
    <basicUdiDi>B-16955792730738</basicUdiDi>
    <tradeName>Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)</tradeName>
    <deviceName>Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3362E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:12:46.608Z</lastUpdated>
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    <udiDi>16955792730721</udiDi>
    <basicUdiDi>B-16955792730721</basicUdiDi>
    <tradeName>Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)</tradeName>
    <deviceName>Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3362E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:12:45.812Z</lastUpdated>
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    <udiDi>16955792730714</udiDi>
    <basicUdiDi>B-16955792730714</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3357E-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:12:27.340Z</lastUpdated>
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    <udiDi>16955792730707</udiDi>
    <basicUdiDi>B-16955792730707</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3357E-25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:12:26.549Z</lastUpdated>
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    <udiDi>16955792730691</udiDi>
    <basicUdiDi>B-16955792730691</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3357E-5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:12:25.746Z</lastUpdated>
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