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    <basicUdiDi>B-06970664752376</basicUdiDi>
    <tradeName>06970664752376</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>7Tests/KIt</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:33:54.181Z</lastUpdated>
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    <udiDi>06970664751577</udiDi>
    <basicUdiDi>B-06970664751577</basicUdiDi>
    <tradeName>06970664751577</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</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>2026-06-30T04:33:04.958Z</lastUpdated>
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    <udiDi>06970664751515</udiDi>
    <basicUdiDi>B-06970664751515</basicUdiDi>
    <tradeName>06970664751515</tradeName>
    <deviceName>COVID-19 Neutralization Antibody Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:58.938Z</lastUpdated>
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    <udiDi>06970664751492</udiDi>
    <basicUdiDi>B-06970664751492</basicUdiDi>
    <tradeName>06970664751492</tradeName>
    <deviceName>COVID-19 Neutralization Antibody Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>25Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:57.738Z</lastUpdated>
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    <udiDi>06970664751485</udiDi>
    <basicUdiDi>B-06970664751485</basicUdiDi>
    <tradeName>06970664751485</tradeName>
    <deviceName>COVID-19 Neutralization Antibody ELISA Test</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>96Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:56.536Z</lastUpdated>
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    <udiDi>06970664751478</udiDi>
    <basicUdiDi>B-06970664751478</basicUdiDi>
    <tradeName>06970664751478</tradeName>
    <deviceName>SARS-COV-2/FIuA/FIuB Antigen Combo Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>25Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:55.343Z</lastUpdated>
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    <udiDi>06970664751393</udiDi>
    <basicUdiDi>B-06970664751393</basicUdiDi>
    <tradeName>06970664751393</tradeName>
    <deviceName>COVID-19 nucleic acid Test kit (fluorescence PCR)</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>50Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:49.334Z</lastUpdated>
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    <udiDi>06970664751386</udiDi>
    <basicUdiDi>B-06970664751386</basicUdiDi>
    <tradeName>06970664751386</tradeName>
    <deviceName>COVID-19 Ab Rapid Test Kit（WB/Serum/Plasma）</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>25Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:48.131Z</lastUpdated>
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    <udiDi>06970664751379</udiDi>
    <basicUdiDi>B-06970664751379</basicUdiDi>
    <tradeName>06970664751379</tradeName>
    <deviceName>COVID-19 Ab Test Kit（ELISA）</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>96Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:46.933Z</lastUpdated>
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    <udiDi>06970664751362</udiDi>
    <basicUdiDi>B-06970664751362</basicUdiDi>
    <tradeName>06970664751362</tradeName>
    <deviceName>COVID-19 Antigen ELISA Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>96Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:45.744Z</lastUpdated>
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    <udiDi>06970664751355</udiDi>
    <basicUdiDi>B-06970664751355</basicUdiDi>
    <tradeName>06970664751355</tradeName>
    <deviceName>COVID-19 IgM Antibody ELISA Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>96Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:39.726Z</lastUpdated>
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    <udiDi>06970664751348</udiDi>
    <basicUdiDi>B-06970664751348</basicUdiDi>
    <tradeName>06970664751348</tradeName>
    <deviceName>COVID-19 IgG Antibody ELISA Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>96Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:38.526Z</lastUpdated>
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    <udiDi>06970664751331</udiDi>
    <basicUdiDi>B-06970664751331</basicUdiDi>
    <tradeName>06970664751331</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:37.325Z</lastUpdated>
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    <udiDi>06970664751324</udiDi>
    <basicUdiDi>B-06970664751324</basicUdiDi>
    <tradeName>06970664751324</tradeName>
    <deviceName>COVID-19 IgG/IgM Antibody Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:36.135Z</lastUpdated>
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    <udiDi>06970664750921</udiDi>
    <basicUdiDi>B-06970664750921</basicUdiDi>
    <tradeName>06970664750921</tradeName>
    <deviceName>COVID-19 IgG/IgM Ab Rapid Test Kit</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:30.123Z</lastUpdated>
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    <udiDi>06970664750396</udiDi>
    <basicUdiDi>B-06970664750396</basicUdiDi>
    <tradeName>06970664750396</tradeName>
    <deviceName>Multiple Real-Time PCR kit for Detection of SARS-CoV-2</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</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>48Tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:32:28.949Z</lastUpdated>
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    <udiDi>06970581432375</udiDi>
    <basicUdiDi>B-06970581432375</basicUdiDi>
    <tradeName>Accu-Tell® Human Monkeypox virus Cassette (Lesion exudate swab)</tradeName>
    <deviceName>Accu-Tell® Human Monkeypox virus Cassette (Lesion exudate swab)</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:57.174Z</lastUpdated>
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    <udiDi>06970581432368</udiDi>
    <basicUdiDi>B-06970581432368</basicUdiDi>
    <tradeName>Accu-Tell® Human Monkeypox virus Antibody Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Human Monkeypox virus Antibody Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B399</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:55.975Z</lastUpdated>
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    <udiDi>06970581432337</udiDi>
    <basicUdiDi>B-06970581432337</basicUdiDi>
    <tradeName>Accu-Tell® COVID-19 Antigen Cassette (Nasal Swab)</tradeName>
    <deviceName>Accu-Tell® COVID-19 Antigen Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B374</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:46.361Z</lastUpdated>
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    <udiDi>06970581432320</udiDi>
    <basicUdiDi>B-06970581432320</basicUdiDi>
    <tradeName>Accu-Tell® COVID-19 Antigen Cassette (Saliva)</tradeName>
    <deviceName>Accu-Tell® COVID-19 Antigen Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B372</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:45.159Z</lastUpdated>
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</eudamedExport>