<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-5E02C1VN</udiDi>
    <basicUdiDi>B-5E02C1VN</basicUdiDi>
    <tradeName>Testosterone Test (FIA)</tradeName>
    <deviceName>Testosterone Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5E02C1-25-EU, 5E02C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:31.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5E01C1VH</udiDi>
    <basicUdiDi>B-5E01C1VH</basicUdiDi>
    <tradeName>Progesterone Test (FIA)</tradeName>
    <deviceName>Progesterone Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5E01C1-25-EU, 5E01C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:27.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5D03C1VG</udiDi>
    <basicUdiDi>B-5D03C1VG</basicUdiDi>
    <tradeName>Prolactin Test (FIA)</tradeName>
    <deviceName>Prolactin Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5D03C1-25-EU, 5D03C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:27.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5D02C1VB</udiDi>
    <basicUdiDi>B-5D02C1VB</basicUdiDi>
    <tradeName>Luteinizing Hormone Test (FIA)</tradeName>
    <deviceName>Luteinizing Hormone Test (FIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</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>5D02C1-25-EU, 5D02C1-50-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:26.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5060337728072UX</udiDi>
    <basicUdiDi>B-5060337728072UX</basicUdiDi>
    <tradeName>Clear&amp;Simple 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>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:18:54.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903347126</udiDi>
    <basicUdiDi>B-06977903347126</basicUdiDi>
    <tradeName>06977903347126</tradeName>
    <deviceName>Rapid Semi-Quantitative HCG Urine Pregnancy Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110315C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:37:44.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976232252200</udiDi>
    <basicUdiDi>B-06976232252200</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Insulin-like Growth Factor Binding Protein-1/Alpha-Fetoprotein (IGFBP-1/AFP) Combo Rapid Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</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>CA01-12-422P15</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:46.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976232251807</udiDi>
    <basicUdiDi>B-06976232251807</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Insulin-like Growth Factor Binding Protein-1/Alpha-Fetoprotein (IGFBP-1/AFP) Combo Rapid</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</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>CA01-12-422P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:01.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976232251760</udiDi>
    <basicUdiDi>B-06976232251760</basicUdiDi>
    <tradeName>Accufast</tradeName>
    <deviceName>Semi-quantitative LH  Ovulation Rapid Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</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>CA01-11-113P10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:31:58.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598216019</udiDi>
    <basicUdiDi>B-06942598216019</basicUdiDi>
    <tradeName>Veroval Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream</tradeName>
    <deviceName>Veroval Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream</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-U103H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:53:07.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942468139202</udiDi>
    <basicUdiDi>B-06942468139202</basicUdiDi>
    <tradeName>vitalio Early 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- M02-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:53:04.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942468139196</udiDi>
    <basicUdiDi>B-06942468139196</basicUdiDi>
    <tradeName>vitalio 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>ACK21002- M02-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:53:03.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942468139189</udiDi>
    <basicUdiDi>B-06942468139189</basicUdiDi>
    <tradeName>vitalio 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-M05-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:53:02.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942468138403</udiDi>
    <basicUdiDi>B-06942468138403</basicUdiDi>
    <tradeName>vitalio 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-M05-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:52:59.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942468138397</udiDi>
    <basicUdiDi>B-06942468138397</basicUdiDi>
    <tradeName>vitalio 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>ACK21002- M02-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:52:58.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942468138380</udiDi>
    <basicUdiDi>B-06942468138380</basicUdiDi>
    <tradeName>vitalio Early 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- M02-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:52:57.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078096501</udiDi>
    <basicUdiDi>B-06934078096501</basicUdiDi>
    <tradeName>Toto Pharma</tradeName>
    <deviceName>hCG Pregnancy Rapid Test Strip (Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</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>WHCG-ES11H</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:26:18.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260173434118</udiDi>
    <basicUdiDi>B-04260173434118</basicUdiDi>
    <tradeName>ZuhauseTEST FSH Rapid Test Midstream</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFS-103H</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:12:47.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260173434071</udiDi>
    <basicUdiDi>B-04260173434071</basicUdiDi>
    <tradeName>ZuhauseTEST Ovulation (LH) Rapid Test Midstream</tradeName>
    <deviceName>ZuhauseTEST Ovulation (LH) Rapid Test Midstream</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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLH-S103H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:12:46.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260173434064</udiDi>
    <basicUdiDi>B-04260173434064</basicUdiDi>
    <tradeName>NanoRepro Pregnancy (hCG)10miu Enhanced Sensitivity Rapid Test Dipstick</tradeName>
    <deviceName>NanoRepro Pregnancy (hCG)10miu Enhanced Sensitivity Rapid Test Dipstick</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-U101H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:12:45.670Z</lastUpdated>
  </row>
</eudamedExport>