<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03573026454173</udiDi>
    <basicUdiDi>357302BUDI000173TA</basicUdiDi>
    <tradeName>VIDAS® AMH</tradeName>
    <deviceName>VIDAS® AMH</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>417011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:47.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026065164</udiDi>
    <basicUdiDi>357302BUDI000010SD</basicUdiDi>
    <tradeName>VIDAS® Estradiol II</tradeName>
    <deviceName>VIDAS® Estradiol II</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30431</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:15.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414573342</udiDi>
    <basicUdiDi>0405686901810VM</basicUdiDi>
    <tradeName>ADVIA Centaur Enhanced Estradiol</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_eE2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10490889</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:48:46.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598857</udiDi>
    <basicUdiDi>0405686901810VM</basicUdiDi>
    <tradeName>Atellica IM Enhanced Estradiol (eE2)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995561</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:45:14.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414574646</udiDi>
    <basicUdiDi>0405686901810VM</basicUdiDi>
    <tradeName>ADVIA Centaur Enhanced Estradiol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10491445</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:45:14.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598864</udiDi>
    <basicUdiDi>0405686901810VM</basicUdiDi>
    <tradeName>Atellica IM Enhanced Estradiol (eE2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_eE2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995562</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:23.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76335FV</udiDi>
    <basicUdiDi>B-DC76335FV</basicUdiDi>
    <tradeName>iStar-DHEA-S</tradeName>
    <deviceName>iStar-DHEA-S</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>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76334</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:42.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76334FT</udiDi>
    <basicUdiDi>B-DC76334FT</basicUdiDi>
    <tradeName>iStar-DHEA-S</tradeName>
    <deviceName>iStar-DHEA-S</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>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76334</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:41.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76333FR</udiDi>
    <basicUdiDi>B-DC76333FR</basicUdiDi>
    <tradeName>iStar-DHEA-S</tradeName>
    <deviceName>iStar-DHEA-S</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>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76333</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:32.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76332FP</udiDi>
    <basicUdiDi>B-DC76332FP</basicUdiDi>
    <tradeName>iStar-SHBG</tradeName>
    <deviceName>iStar-SHBG</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>W0102050109</emdnCode>
    <emdnDescription>SEX HORMONE BINDING GLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76332</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:30.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76331FM</udiDi>
    <basicUdiDi>B-DC76331FM</basicUdiDi>
    <tradeName>iStar-SHBG</tradeName>
    <deviceName>iStar-SHBG</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>W0102050109</emdnCode>
    <emdnDescription>SEX HORMONE BINDING GLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76331</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:29.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76330FK</udiDi>
    <basicUdiDi>B-DC76330FK</basicUdiDi>
    <tradeName>iStar-SHBG</tradeName>
    <deviceName>iStar-SHBG</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>W0102050109</emdnCode>
    <emdnDescription>SEX HORMONE BINDING GLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76330</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:26.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76329G2</udiDi>
    <basicUdiDi>B-DC76329G2</basicUdiDi>
    <tradeName>iStar-Inhibin B</tradeName>
    <deviceName>iStar-Inhibin B</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>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76329</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:18.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76328FY</udiDi>
    <basicUdiDi>B-DC76328FY</basicUdiDi>
    <tradeName>iStar-Inhibin B</tradeName>
    <deviceName>iStar-Inhibin B</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>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76328</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:17.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76327FW</udiDi>
    <basicUdiDi>B-DC76327FW</basicUdiDi>
    <tradeName>iStar-Inhibin B</tradeName>
    <deviceName>iStar-Inhibin B</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>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76327</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:13.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76326FU</udiDi>
    <basicUdiDi>B-DC76326FU</basicUdiDi>
    <tradeName>iStar-AMH</tradeName>
    <deviceName>iStar-AMH</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>DC76326</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:13.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76325FS</udiDi>
    <basicUdiDi>B-DC76325FS</basicUdiDi>
    <tradeName>iStar-AMH</tradeName>
    <deviceName>iStar-AMH</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>DC76325</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:04.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76324FQ</udiDi>
    <basicUdiDi>B-DC76324FQ</basicUdiDi>
    <tradeName>iStar-AMH</tradeName>
    <deviceName>iStar-AMH</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>DC76324</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:59:01.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76028FH</udiDi>
    <basicUdiDi>B-DC76028FH</basicUdiDi>
    <tradeName>iStar-DHEA-S</tradeName>
    <deviceName>iStar-DHEA-S</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>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76028</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:58:58.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CI-LHUC</udiDi>
    <basicUdiDi>B-CI-LHUC</basicUdiDi>
    <tradeName>LH Test Kit (CLIA)</tradeName>
    <deviceName>LH Test Kit (CLIA)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CI-LH</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:02.849Z</lastUpdated>
  </row>
</eudamedExport>