<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06977194142288</udiDi>
    <basicUdiDi>B-06977194142288</basicUdiDi>
    <tradeName>06977194142288</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0519003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:14:22.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194142271</udiDi>
    <basicUdiDi>B-06977194142271</basicUdiDi>
    <tradeName>06977194142271</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0519002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:14:20.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194142264</udiDi>
    <basicUdiDi>B-06977194142264</basicUdiDi>
    <tradeName>06977194142264</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0519001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:14:18.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141793</udiDi>
    <basicUdiDi>B-06977194141793</basicUdiDi>
    <tradeName>06977194141793</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0202901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:38.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141786</udiDi>
    <basicUdiDi>B-06977194141786</basicUdiDi>
    <tradeName>06977194141786</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0202801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:36.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141779</udiDi>
    <basicUdiDi>B-06977194141779</basicUdiDi>
    <tradeName>06977194141779</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0202701</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:35.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141625</udiDi>
    <basicUdiDi>B-06977194141625</basicUdiDi>
    <tradeName>06977194141625</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0200901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:10.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141618</udiDi>
    <basicUdiDi>B-06977194141618</basicUdiDi>
    <tradeName>06977194141618</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0200801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:12:09.612Z</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>D-03701077402397D4</udiDi>
    <basicUdiDi>B-03701077402397D4</basicUdiDi>
    <tradeName>Test de Grossesse Sanguin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NG Biotech</manufacturerName>
    <manufacturerSrn>FR-MF-000016216</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB-HCG-W23-028</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:54:24.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>00628347568214</udiDi>
    <basicUdiDi>B-00628347568214</basicUdiDi>
    <tradeName>Heltes</tradeName>
    <deviceName>Male Fertility Sperm Tests for Self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-06-422HT1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:23:25.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>00628347568160</udiDi>
    <basicUdiDi>B-00628347568160</basicUdiDi>
    <tradeName>Valfast</tradeName>
    <deviceName>Male Fertility Sperm Tests for Self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-06-422VF1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:23:18.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>00628347568122</udiDi>
    <basicUdiDi>B-00628347568122</basicUdiDi>
    <tradeName>apotekets</tradeName>
    <deviceName>Male Fertility Sperm Tests for Self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-06-422AK1</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:23:11.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>00628347568115</udiDi>
    <basicUdiDi>B-00628347568115</basicUdiDi>
    <tradeName>Accufast</tradeName>
    <deviceName>Male Fertility Sperm Tests for Self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-06-422AF1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:23:11.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>00628347568092</udiDi>
    <basicUdiDi>B-00628347568092</basicUdiDi>
    <tradeName>Be Sure</tradeName>
    <deviceName>Male Fertility Sperm Tests for self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-06-422BS1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:23:06.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208586</udiDi>
    <basicUdiDi>69332602IF0100044ZW</basicUdiDi>
    <tradeName>06933260208586</tradeName>
    <deviceName>AMH Rapid Quantitative Test</deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT0208801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:53:07.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955009300443</udiDi>
    <basicUdiDi>B-06955009300443</basicUdiDi>
    <tradeName>HUAC</tradeName>
    <deviceName>Digital Pregnancy &amp; Ovulation Test</deviceName>
    <manufacturerName>Tianjin HUAC Healthcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038800</manufacturerSrn>
    <authorisedRepresentativeName>Brückenkopf GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000038468</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06955009300443</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:44:54.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663987103</udiDi>
    <basicUdiDi>B-06939663987103</basicUdiDi>
    <tradeName>Digital Fertility Testing System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Digital Fertility Tracker and LH One Step Ovulation Test</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:05:19.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209894</udiDi>
    <basicUdiDi>B-06937339209894</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VHIG-702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:57:29.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209597</udiDi>
    <basicUdiDi>B-06937339209597</basicUdiDi>
    <tradeName>PROM Amniotic fluid Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VHPA-702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:46.971Z</lastUpdated>
  </row>
</eudamedExport>