<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-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-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-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>
  <row>
    <udiDi>D-EZM1-H3YP</udiDi>
    <basicUdiDi>B-EZM1-H3YP</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>EZM1-H3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:09:26.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180726001MY</udiDi>
    <basicUdiDi>B-CNM0000180726001MY</basicUdiDi>
    <tradeName>D-CNM0000180726001MY</tradeName>
    <deviceName>One-Step HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6001C  6001S  6001D 6001B</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:23.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACK21001-S02-018AS</udiDi>
    <basicUdiDi>B-ACK21001-S02-018AS</basicUdiDi>
    <tradeName>Dr. Max Pregnancy Test 2in1</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK21001-S02-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:13.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACK21001-M01-01879</udiDi>
    <basicUdiDi>B-ACK21001-M01-01879</basicUdiDi>
    <tradeName>Dr. Max Pregnancy Test Comfort</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK21001-M01-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:11.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACK21001-C01-018ZU</udiDi>
    <basicUdiDi>B-ACK21001-C01-018ZU</basicUdiDi>
    <tradeName>Dr. Max Pregnancy Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK21001-C01-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:09.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-C123</udiDi>
    <basicUdiDi>B-ABT-FT-C123</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test</tradeName>
    <deviceName>One Step HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-C1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:58.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-C387PM</udiDi>
    <basicUdiDi>B-ABT-FT-C387PM</basicUdiDi>
    <tradeName>Accu-Tell® HCG Multi-Line Midstream (Urine)</tradeName>
    <deviceName>Accu-Tell® HCG Multi-Line Midstream (Urine)</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-C387</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:56.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-B1ZV</udiDi>
    <basicUdiDi>B-ABT-FT-B1ZV</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test</tradeName>
    <deviceName>One Step HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-B1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:38.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-A387P7</udiDi>
    <basicUdiDi>B-ABT-FT-A387P7</basicUdiDi>
    <tradeName>Accu-Tell® HCG Multi-Line Strip (Urine)</tradeName>
    <deviceName>Accu-Tell® HCG Multi-Line Strip (Urine)</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-A387</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:36.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-A1ZS</udiDi>
    <basicUdiDi>B-ABT-FT-A1ZS</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test</tradeName>
    <deviceName>One Step HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-A1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:32.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8595566428563GB</udiDi>
    <basicUdiDi>B-8595566428563GB</basicUdiDi>
    <tradeName>Dr. Max Digital Pregnancy Rapid Test</tradeName>
    <deviceName>Digital Pregnancy Rapid Test</deviceName>
    <manufacturerName>Guangzhou Decheng Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013536</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>0811S7X001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:19:36.060Z</lastUpdated>
  </row>
</eudamedExport>