<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-EIM4201002DZ</udiDi>
    <basicUdiDi>B-EIM4201002DZ</basicUdiDi>
    <tradeName>D-EIM4201002DZ</tradeName>
    <deviceName>free β-HCG</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4201002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:43.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4201001DX</udiDi>
    <basicUdiDi>B-EIM4201001DX</basicUdiDi>
    <tradeName>D-EIM4201001DX</tradeName>
    <deviceName>HCG</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4201001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:41.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-De-MF-000031456KY</udiDi>
    <basicUdiDi>B-De-MF-000031456KY</basicUdiDi>
    <tradeName>SERATEC Deluxe Frühtest</tradeName>
    <deviceName>SERATEC Deluxe Frühtest</deviceName>
    <manufacturerName>SERATEC Gesellschaft für Biotechnologie mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000031456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG-M2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:33.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01687R</udiDi>
    <basicUdiDi>B-DT01687R</basicUdiDi>
    <tradeName>β-HCG</tradeName>
    <deviceName>β-HCG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0168</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:23.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01677P</udiDi>
    <basicUdiDi>B-DT01677P</basicUdiDi>
    <tradeName>β-HCG</tradeName>
    <deviceName>β-HCG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0167</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:21.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT00917F</udiDi>
    <basicUdiDi>B-DT00917F</basicUdiDi>
    <tradeName>Unicorn-AMH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0091</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:16:13.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT00817C</udiDi>
    <basicUdiDi>B-DT00817C</basicUdiDi>
    <tradeName>Unicorn-β-HCG</tradeName>
    <deviceName>Unicorn-β-HCG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0081</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:15:47.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT005275</udiDi>
    <basicUdiDi>B-DT005275</basicUdiDi>
    <tradeName>Unicorn-AMH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0052</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:14:46.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT001773</udiDi>
    <basicUdiDi>B-DT001773</basicUdiDi>
    <tradeName>Unicorn-β-HCG</tradeName>
    <deviceName>Unicorn-β-HCG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:14:33.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76233FL</udiDi>
    <basicUdiDi>B-DC76233FL</basicUdiDi>
    <tradeName>iStar-HCG</tradeName>
    <deviceName>iStar-HCG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76233</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:08:32.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76232FJ</udiDi>
    <basicUdiDi>B-DC76232FJ</basicUdiDi>
    <tradeName>iStar-HCG</tradeName>
    <deviceName>iStar-HCG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76232</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:08:31.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76231FG</udiDi>
    <basicUdiDi>B-DC76231FG</basicUdiDi>
    <tradeName>iStar-HCG</tradeName>
    <deviceName>iStar-HCG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76230</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:08:29.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76230FE</udiDi>
    <basicUdiDi>B-DC76230FE</basicUdiDi>
    <tradeName>iStar-HCG</tradeName>
    <deviceName>iStar-HCG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76230</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:08:27.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76007F9</udiDi>
    <basicUdiDi>B-DC76007F9</basicUdiDi>
    <tradeName>iStar-HCG</tradeName>
    <deviceName>iStar-HCG</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:29.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349YS002PY</udiDi>
    <basicUdiDi>B-CNMF000054349YS002PY</basicUdiDi>
    <tradeName>HCG Rapid Test Kit</tradeName>
    <deviceName>HCG Rapid Test Kit</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>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YS002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:32.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AMH706-AERM</udiDi>
    <basicUdiDi>B-AMH706-AERM</basicUdiDi>
    <tradeName>AMH Anti-Müllerian Hormone (CLIA)</tradeName>
    <deviceName>AMH Anti-Müllerian Hormone (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMH706-AE10Y, AMH706-AE10N, AMH706-AE20Y, AMH706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:24.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AL-1963A</udiDi>
    <basicUdiDi>B-AL-1963A</basicUdiDi>
    <tradeName>AL-196</tradeName>
    <deviceName>AL-196-I - PCO Check AMH ELISA (CE)</deviceName>
    <manufacturerName>Ansh Labs</manufacturerName>
    <manufacturerSrn>US-MF-000054510</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL-196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:34:31.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AL-19538</udiDi>
    <basicUdiDi>B-AL-19538</basicUdiDi>
    <tradeName>AL-195-I - US Inhibin B ELISA (CE)</tradeName>
    <deviceName>AL-195-I - US Inhibin B ELISA (CE)</deviceName>
    <manufacturerName>Ansh Labs</manufacturerName>
    <manufacturerSrn>US-MF-000054510</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL-195</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:34:30.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AL-1382U</udiDi>
    <basicUdiDi>B-AL-1382U</basicUdiDi>
    <tradeName>AL-138-I - Estriol EIA (CE)</tradeName>
    <deviceName>AL-138-I - Estriol EIA (CE)</deviceName>
    <manufacturerName>Ansh Labs</manufacturerName>
    <manufacturerSrn>US-MF-000054510</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL-138</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:34:25.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AL-1292T</udiDi>
    <basicUdiDi>B-AL-1292T</basicUdiDi>
    <tradeName>AL-129-I - DBS AMH ELISA</tradeName>
    <deviceName>AL-129-I - DBS AMH ELISA</deviceName>
    <manufacturerName>Ansh Labs</manufacturerName>
    <manufacturerSrn>US-MF-000054510</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL-129</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:34:24.774Z</lastUpdated>
  </row>
</eudamedExport>