<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975132463457</udiDi>
    <basicUdiDi>B-06975132463457</basicUdiDi>
    <tradeName>06975132463457</tradeName>
    <deviceName>Luteinizing hormone Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLH-102G-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:50.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132463440</udiDi>
    <basicUdiDi>B-06975132463440</basicUdiDi>
    <tradeName>06975132463440</tradeName>
    <deviceName>Luteinizing hormone Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLH-103G-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:49.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132463433</udiDi>
    <basicUdiDi>B-06975132463433</basicUdiDi>
    <tradeName>06975132463433</tradeName>
    <deviceName>Luteinizing hormone Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLH-101G-100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:34.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132463426</udiDi>
    <basicUdiDi>B-06975132463426</basicUdiDi>
    <tradeName>06975132463426</tradeName>
    <deviceName>Luteinizing hormone Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLH-101G-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:33.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132463419</udiDi>
    <basicUdiDi>B-06975132463419</basicUdiDi>
    <tradeName>06975132463419</tradeName>
    <deviceName>Luteinizing hormone Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLH-101G-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:29.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132463365</udiDi>
    <basicUdiDi>B-06975132463365</basicUdiDi>
    <tradeName>06975132463365</tradeName>
    <deviceName>Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCG-102G-25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:28.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132463358</udiDi>
    <basicUdiDi>B-06975132463358</basicUdiDi>
    <tradeName>06975132463358</tradeName>
    <deviceName>Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCG-102G-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:28.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132463341</udiDi>
    <basicUdiDi>B-06975132463341</basicUdiDi>
    <tradeName>06975132463341</tradeName>
    <deviceName>Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCG-103G-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:27.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132463334</udiDi>
    <basicUdiDi>B-06975132463334</basicUdiDi>
    <tradeName>06975132463334</tradeName>
    <deviceName>Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCG-101G-100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:23.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132463327</udiDi>
    <basicUdiDi>B-06975132463327</basicUdiDi>
    <tradeName>06975132463327</tradeName>
    <deviceName>Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCG-101G-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:22.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975132463310</udiDi>
    <basicUdiDi>B-06975132463310</basicUdiDi>
    <tradeName>06975132463310</tradeName>
    <deviceName>Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Jiangsu Accuracy Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004533</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCG-101G-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:59:21.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974912093839</udiDi>
    <basicUdiDi>B-06974912093839</basicUdiDi>
    <tradeName>POCBio Pregnancy(hCG) Rapid Test</tradeName>
    <deviceName>POCBio Pregnancy(hCG) Rapid Test</deviceName>
    <manufacturerName>Nexlab Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047094</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LATW01-C50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:02:20.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674891544</udiDi>
    <basicUdiDi>B-06974674891544</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone (FSH) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0104</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:27.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674891537</udiDi>
    <basicUdiDi>B-06974674891537</basicUdiDi>
    <tradeName>Luteinizing Hormone (LH) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Luteinizing Hormone (LH) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0103</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:25.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674891520</udiDi>
    <basicUdiDi>B-06974674891520</basicUdiDi>
    <tradeName>Beta Subunit of Human Chorionic Gonadotropin (β-HCG) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Beta Subunit of Human Chorionic Gonadotropin (β-HCG) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:23.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565523</udiDi>
    <basicUdiDi>B-06974541565523</basicUdiDi>
    <tradeName>06974541565523</tradeName>
    <deviceName>Saliva Pregnancy Test Kit</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2235</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:34.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565486</udiDi>
    <basicUdiDi>B-06974541565486</basicUdiDi>
    <tradeName>06974541565486</tradeName>
    <deviceName>Luteinising Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2230</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:28.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565479</udiDi>
    <basicUdiDi>B-06974541565479</basicUdiDi>
    <tradeName>06974541565479</tradeName>
    <deviceName>Luteinising Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2230</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:27.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565462</udiDi>
    <basicUdiDi>B-06974541565462</basicUdiDi>
    <tradeName>06974541565462</tradeName>
    <deviceName>Luteinising Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2230</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:26.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565448</udiDi>
    <basicUdiDi>B-06974541565448</basicUdiDi>
    <tradeName>06974541565448</tradeName>
    <deviceName>ollicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2229</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:22.147Z</lastUpdated>
  </row>
</eudamedExport>