<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FHC-ER103WD</udiDi>
    <basicUdiDi>B-FHC-ER103WD</basicUdiDi>
    <tradeName>Digital Pregnancy Test</tradeName>
    <deviceName>Digital Pregnancy Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-ER103</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:25.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-E103HQR</udiDi>
    <basicUdiDi>B-FHC-E103HQR</basicUdiDi>
    <tradeName>Digital hCG Pregnancy Test</tradeName>
    <deviceName>Digital hCG Pregnancy Test</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-E103H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:23.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-201L4</udiDi>
    <basicUdiDi>B-FHC-201L4</basicUdiDi>
    <tradeName>D-FHC-201L4</tradeName>
    <deviceName>hCG One Step Pregnancy Test Strip (Urine/Serum)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:23.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-102KZ</udiDi>
    <basicUdiDi>B-FHC-102KZ</basicUdiDi>
    <tradeName>D-FHC-102KZ</tradeName>
    <deviceName>hCG One Step Pregnancy Test Device (Urine)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:20.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-101KX</udiDi>
    <basicUdiDi>B-FHC-101KX</basicUdiDi>
    <tradeName>D-FHC-101KX</tradeName>
    <deviceName>hCG One Step Pregnancy Test Strip (Urine)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:18.118Z</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-FAHCG-402aQ5</udiDi>
    <basicUdiDi>B-FAHCG-402aQ5</basicUdiDi>
    <tradeName>β-hCG Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>β-hCG 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAHCG-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:10.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAHCG-402aHGKV</udiDi>
    <basicUdiDi>B-FAHCG-402aHGKV</basicUdiDi>
    <tradeName>β-hCG 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAHCG-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:09.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAFSH-402aXU</udiDi>
    <basicUdiDi>B-FAFSH-402aXU</basicUdiDi>
    <tradeName>FSH Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>FSH 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>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAFSH-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:48.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAFSH-402aHGW6</udiDi>
    <basicUdiDi>B-FAFSH-402aHGW6</basicUdiDi>
    <tradeName>FSH 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>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAFSH-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:48.135Z</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-FA0020YW</udiDi>
    <basicUdiDi>B-FA0020YW</basicUdiDi>
    <tradeName>D-FA0020YW</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) 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>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52027075</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:50.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F001-1001RH</udiDi>
    <basicUdiDi>B-F001-1001RH</basicUdiDi>
    <tradeName>Pregnancy (hCG) Rapid Test</tradeName>
    <deviceName>Pregnancy (hCG) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Tongzhou Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038774</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F001-1001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:10:23.747Z</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-EZW1-SKB</udiDi>
    <basicUdiDi>B-EZW1-SKB</basicUdiDi>
    <tradeName>Easy@Home Pregnancy Test</tradeName>
    <deviceName>Easy@Home Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EZW1-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:09:34.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EZW1-S-5PM</udiDi>
    <basicUdiDi>B-EZW1-S-5PM</basicUdiDi>
    <tradeName>Easy @ Home Pregnancy Test</tradeName>
    <deviceName>Easy@Home Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EZW1-S-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:09:32.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EZW1-S-20CD</udiDi>
    <basicUdiDi>B-EZW1-S-20CD</basicUdiDi>
    <tradeName>Easy@Home Pregnancy Test</tradeName>
    <deviceName>Easy@Home Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EZW1-S-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:09:30.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EZW1-MN-5FW</udiDi>
    <basicUdiDi>B-EZW1-MN-5FW</basicUdiDi>
    <tradeName>Easy @ Home Pregnancy Test</tradeName>
    <deviceName>Easy@Home Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EZW1-MN-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:09:30.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EZW1-MN-2FQ</udiDi>
    <basicUdiDi>B-EZW1-MN-2FQ</basicUdiDi>
    <tradeName>Easy @ Home Pregnancy Test</tradeName>
    <deviceName>Easy@Home Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EZW1-MN-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:09:28.466Z</lastUpdated>
  </row>
</eudamedExport>