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    <udiDi>06970877689025</udiDi>
    <basicUdiDi>B-06970877689025</basicUdiDi>
    <tradeName>DNA/RNA Extraction Kit(Magnetic beads method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0902</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:57.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970877689018</udiDi>
    <basicUdiDi>B-06970877689018</basicUdiDi>
    <tradeName>DNA/RNA Extraction Kit(Magnetic beads method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:51.555Z</lastUpdated>
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    <udiDi>06970877688004</udiDi>
    <basicUdiDi>B-06970877688004</basicUdiDi>
    <tradeName>cTnI/ Myoglobin Test Kit（colloidal gold immunochromatographic assay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:50.355Z</lastUpdated>
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    <udiDi>06970877687007</udiDi>
    <basicUdiDi>B-06970877687007</basicUdiDi>
    <tradeName>cTnI Test Kit（colloidal gold immunochromatographic assay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:49.158Z</lastUpdated>
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  <row>
    <udiDi>06970877686000</udiDi>
    <basicUdiDi>B-06970877686000</basicUdiDi>
    <tradeName>cTnI/CK-MB/Myoglobin Test Kit（colloidal gold immunochromatographic assay）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:47.957Z</lastUpdated>
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  <row>
    <udiDi>06970877685027</udiDi>
    <basicUdiDi>B-06970877685027</basicUdiDi>
    <tradeName>DNA &amp;RNA Purification Kit For MagMaX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:41.955Z</lastUpdated>
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  <row>
    <udiDi>06970877685010</udiDi>
    <basicUdiDi>B-06970877685010</basicUdiDi>
    <tradeName>DNA &amp;RNA Purification Kit For MagMaX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:40.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970877684037</udiDi>
    <basicUdiDi>B-06970877684037</basicUdiDi>
    <tradeName>Nucleic Acid Diagnostic Kit for SARS-CoV-2(Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0403</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:39.554Z</lastUpdated>
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  <row>
    <udiDi>06970877684020</udiDi>
    <basicUdiDi>B-06970877684020</basicUdiDi>
    <tradeName>Nucleic Acid Diagnostic Kit for SARS-CoV-2(Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:38.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970877684013</udiDi>
    <basicUdiDi>B-06970877684013</basicUdiDi>
    <tradeName>Nucleic Acid Diagnostic Kit for SARS-CoV-2(Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:32.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970877683023</udiDi>
    <basicUdiDi>B-06970877683023</basicUdiDi>
    <tradeName>COVID-19 SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:31.145Z</lastUpdated>
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  <row>
    <udiDi>06970877683016</udiDi>
    <basicUdiDi>B-06970877683016</basicUdiDi>
    <tradeName>COVID-19 SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0302</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:29.948Z</lastUpdated>
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  <row>
    <udiDi>06970877683009</udiDi>
    <basicUdiDi>B-06970877683009</basicUdiDi>
    <tradeName>COVID-19 SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:28.745Z</lastUpdated>
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  <row>
    <udiDi>06970877682019</udiDi>
    <basicUdiDi>B-06970877682019</basicUdiDi>
    <tradeName>SARS-CoV-2 IgG Antibody Test Kit (Fluorescence immunochromatography)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:22.810Z</lastUpdated>
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  <row>
    <udiDi>06970877681333</udiDi>
    <basicUdiDi>B-06970877681333</basicUdiDi>
    <tradeName>Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1203</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:21.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970877681326</udiDi>
    <basicUdiDi>B-06970877681326</basicUdiDi>
    <tradeName>Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:20.344Z</lastUpdated>
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  <row>
    <udiDi>06970877681319</udiDi>
    <basicUdiDi>B-06970877681319</basicUdiDi>
    <tradeName>Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:19.141Z</lastUpdated>
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    <udiDi>06970877681210</udiDi>
    <basicUdiDi>B-06970877681210</basicUdiDi>
    <tradeName>Diagnostic Kit for Group A Rotavirus  (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:13.131Z</lastUpdated>
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    <udiDi>06970877681135</udiDi>
    <basicUdiDi>B-06970877681135</basicUdiDi>
    <tradeName>Diagnostic Kit for Helicobacter pylori urease antibody (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:11.931Z</lastUpdated>
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    <udiDi>06970877681111</udiDi>
    <basicUdiDi>B-06970877681111</basicUdiDi>
    <tradeName>Diagnostic Kit for Helicobacter pylori urease antibody (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kangmei Tianhong Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014412</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:32:10.731Z</lastUpdated>
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