<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>06974541565431</udiDi>
    <basicUdiDi>B-06974541565431</basicUdiDi>
    <tradeName>06974541565431</tradeName>
    <deviceName>Follicle-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>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:21.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565424</udiDi>
    <basicUdiDi>B-06974541565424</basicUdiDi>
    <tradeName>06974541565424</tradeName>
    <deviceName>Follicle-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>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:19.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565400</udiDi>
    <basicUdiDi>B-06974541565400</basicUdiDi>
    <tradeName>06974541565400</tradeName>
    <deviceName>Human chorionic gonadotropin (HCG) 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2225</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:15.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565394</udiDi>
    <basicUdiDi>B-06974541565394</basicUdiDi>
    <tradeName>06974541565394</tradeName>
    <deviceName>Human chorionic gonadotropin (HCG) 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2225</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:14.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565387</udiDi>
    <basicUdiDi>B-06974541565387</basicUdiDi>
    <tradeName>06974541565387</tradeName>
    <deviceName>Human chorionic gonadotropin (HCG) 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2225</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:13.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521002277</udiDi>
    <basicUdiDi>B-06974521002277</basicUdiDi>
    <tradeName>Progesterone (PROG) Rapid Quantitative Test Kit (FIA)</tradeName>
    <deviceName>Progesterone (PROG) Rapid Quantitative Test Kit (FIA)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPF123024</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:32:13.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974246460789</udiDi>
    <basicUdiDi>B-06974246460789</basicUdiDi>
    <tradeName>hCG Pregnancy Test For Self testing</tradeName>
    <deviceName>hCG Pregnancy Test For Self testing</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG-1011/HCG-1012/HCG-1013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:38:11.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973841001144</udiDi>
    <basicUdiDi>B-06973841001144</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Follicle Stimulating Hormone Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Guangdong Wesail Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008828</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA0380</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:39:28.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973841001137</udiDi>
    <basicUdiDi>B-06973841001137</basicUdiDi>
    <tradeName>Luteinizing Hormone Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Luteinizing Hormone Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Guangdong Wesail Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008828</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>BA0300</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:39:28.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973316742343</udiDi>
    <basicUdiDi>B-06973316742343</basicUdiDi>
    <tradeName>06973316742343</tradeName>
    <deviceName>Follicle-stimulating Hormone (FSH) Fluorescence ImmunoAssay (FIA) Test</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</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>R331083</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:34.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973316742336</udiDi>
    <basicUdiDi>B-06973316742336</basicUdiDi>
    <tradeName>06973316742336</tradeName>
    <deviceName>Follicle-stimulating Hormone (FSH) Fluorescence ImmunoAssay (FIA) Test</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</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>R331082</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:34.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973316742329</udiDi>
    <basicUdiDi>B-06973316742329</basicUdiDi>
    <tradeName>06973316742329</tradeName>
    <deviceName>Follicle-stimulating Hormone (FSH) Fluorescence ImmunoAssay (FIA) Test</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</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>R331081</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:33.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973316742312</udiDi>
    <basicUdiDi>B-06973316742312</basicUdiDi>
    <tradeName>06973316742312</tradeName>
    <deviceName>Follicle-stimulating Hormone (FSH) Fluorescence ImmunoAssay (FIA) Test</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</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>R331080</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:29.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973316742244</udiDi>
    <basicUdiDi>B-06973316742244</basicUdiDi>
    <tradeName>06973316742244</tradeName>
    <deviceName>Luteinizing Hormone (LH) Fluorescence ImmunoAssay (FIA) Test</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</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>R331093</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:27.764Z</lastUpdated>
  </row>
</eudamedExport>