<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GALH-101a-10TGA</udiDi>
    <basicUdiDi>B-GALH-101a-10TGA</basicUdiDi>
    <tradeName>LH Ovulation Rapid Test</tradeName>
    <deviceName>LH Ovulation Rapid Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GALH-101a-10T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:12:32.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FLH-R102C5</udiDi>
    <basicUdiDi>B-FLH-R102C5</basicUdiDi>
    <tradeName>LH Ovulation Rapid Test Cassette</tradeName>
    <deviceName>LH Ovulation Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLH-R102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:36:14.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FALH-402aVU</udiDi>
    <basicUdiDi>B-FALH-402aVU</basicUdiDi>
    <tradeName>LH Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>LH Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>FALH-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:16.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FALH-402aHGJ2</udiDi>
    <basicUdiDi>B-FALH-402aHGJ2</basicUdiDi>
    <tradeName>LH Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</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>FALH-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:15.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FA0021YY</udiDi>
    <basicUdiDi>B-FA0021YY</basicUdiDi>
    <tradeName>Luteinizing Hormone (LH)Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Luteinizing Hormone (LH)Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</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>52027076</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:09.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EZW2-SKG</udiDi>
    <basicUdiDi>B-EZW2-SKG</basicUdiDi>
    <tradeName>Easy@Home Ovulation Test</tradeName>
    <deviceName>Easy@Home Ovulation Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EZW2-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:09:36.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349YS001PW</udiDi>
    <basicUdiDi>B-CNMF000054349YS001PW</basicUdiDi>
    <tradeName>LH Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>LH Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YS001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:28.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180726002N2</udiDi>
    <basicUdiDi>B-CNM0000180726002N2</basicUdiDi>
    <tradeName>D-CNM0000180726002N2</tradeName>
    <deviceName>One-Step LH Ovulation Test</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6002S 6002C 6002D</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:24.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACK21003-S07-016DT</udiDi>
    <basicUdiDi>B-ACK21003-S07-016DT</basicUdiDi>
    <tradeName>Dr. Max Ovulation Test</tradeName>
    <deviceName>LH Ovulation Tests</deviceName>
    <manufacturerName>Core Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023522</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK21003-S07-016</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:15.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-C327</udiDi>
    <basicUdiDi>B-ABT-FT-C327</basicUdiDi>
    <tradeName>One Step LH Ovulation Test</tradeName>
    <deviceName>One Step LH Ovulation Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-C3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:56.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-B324</udiDi>
    <basicUdiDi>B-ABT-FT-B324</basicUdiDi>
    <tradeName>One Step LH Ovulation Test</tradeName>
    <deviceName>One Step LH Ovulation Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-B3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:39.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-A3ZW</udiDi>
    <basicUdiDi>B-ABT-FT-A3ZW</basicUdiDi>
    <tradeName>One Step LH Ovulation Test</tradeName>
    <deviceName>One Step LH Ovulation Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-A3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:37.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808181QN</udiDi>
    <basicUdiDi>B-808181QN</basicUdiDi>
    <tradeName>D-808181QN</tradeName>
    <deviceName>LH Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808181</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:27.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808127QG</udiDi>
    <basicUdiDi>B-808127QG</basicUdiDi>
    <tradeName>D-808127QG</tradeName>
    <deviceName>LH Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808127</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:54:26.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4719872951964C8</udiDi>
    <basicUdiDi>B-4719872951964C8</basicUdiDi>
    <tradeName>Eveline Ovulation Test</tradeName>
    <deviceName>LH Ovulation Test</deviceName>
    <manufacturerName>iXensor Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000026279</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHM-A01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:24.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-32573</udiDi>
    <basicUdiDi>B-32573</basicUdiDi>
    <tradeName>D-32573</tradeName>
    <deviceName>Luteotropic Hormone Quantitative Detection KIT (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:18:15.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>26957290300120</udiDi>
    <basicUdiDi>B-26957290300120</basicUdiDi>
    <tradeName>APTEO</tradeName>
    <deviceName>One Step LH Ovulation Test</deviceName>
    <manufacturerName>Hubei MEIBAO Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019986</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LH-M30A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:51:52.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>26957290300144</udiDi>
    <basicUdiDi>B-26957290300144</basicUdiDi>
    <tradeName>apotekets</tradeName>
    <deviceName>One Step LH Ovulation Test</deviceName>
    <manufacturerName>Hubei MEIBAO Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019986</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LH-M50A</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:51:50.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>26957290300090</udiDi>
    <basicUdiDi>B-26957290300090</basicUdiDi>
    <tradeName>Docteur B</tradeName>
    <deviceName>One Step LH Ovulation Test</deviceName>
    <manufacturerName>Hubei MEIBAO Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019986</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LH-M35A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:51:32.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>26957290300007</udiDi>
    <basicUdiDi>B-26957290300007</basicUdiDi>
    <tradeName>Romed</tradeName>
    <deviceName>One Step LH Ovulation Test</deviceName>
    <manufacturerName>Hubei MEIBAO Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019986</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LH-S3.0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:51:23.966Z</lastUpdated>
  </row>
</eudamedExport>