<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DT01597Q</udiDi>
    <basicUdiDi>B-DT01597Q</basicUdiDi>
    <tradeName>Unicorn-Cortisol</tradeName>
    <deviceName>Unicorn-Cortisol</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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0159</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:08.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT016079</udiDi>
    <basicUdiDi>B-DT016079</basicUdiDi>
    <tradeName>Unicorn-Cortisol</tradeName>
    <deviceName>Unicorn-Cortisol</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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0160</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:06.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76512FT</udiDi>
    <basicUdiDi>B-DC76512FT</basicUdiDi>
    <tradeName>iStar-Cortisol</tradeName>
    <deviceName>iStar-Cortisol</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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76512</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:23.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76511FR</udiDi>
    <basicUdiDi>B-DC76511FR</basicUdiDi>
    <tradeName>iStar-Cortisol</tradeName>
    <deviceName>iStar-Cortisol</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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76511</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:21.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76510FP</udiDi>
    <basicUdiDi>B-DC76510FP</basicUdiDi>
    <tradeName>iStar-Cortisol</tradeName>
    <deviceName>iStar-Cortisol</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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76510</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:20.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76094FW</udiDi>
    <basicUdiDi>B-DC76094FW</basicUdiDi>
    <tradeName>iStar-Cortisol</tradeName>
    <deviceName>iStar-Cortisol</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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76094</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:04:31.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-COR706-AEZK</udiDi>
    <basicUdiDi>B-COR706-AEZK</basicUdiDi>
    <tradeName>Cortisol (CLIA)</tradeName>
    <deviceName>Cortisol (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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COR706-AE10Y, COR706-AE10N, COR706-AE20Y, COR706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:19:47.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ALD706-AENW</udiDi>
    <basicUdiDi>B-ALD706-AENW</basicUdiDi>
    <tradeName>ALD Aldosterone (CLIA)</tradeName>
    <deviceName>ALD Aldosterone (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>W0102060201</emdnCode>
    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALD706-AE10Y, ALD706-AE10N, ALD706-AE20Y, ALD706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:05.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACTH706-AERL</udiDi>
    <basicUdiDi>B-ACTH706-AERL</basicUdiDi>
    <tradeName>ACTH Adrenocorticotropic Hormone (CLIA)</tradeName>
    <deviceName>ACTH Adrenocorticotropic 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>W0102060299</emdnCode>
    <emdnDescription>RENAL METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACTH706-AE10Y, ACTH706-AE10N, ACTH706-AE20Y, ACTH706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:16.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81H40TSCT7</udiDi>
    <basicUdiDi>B-81H40TSCT7</basicUdiDi>
    <tradeName>Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81H40TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:05.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81H160TSC9N</udiDi>
    <basicUdiDi>B-81H160TSC9N</basicUdiDi>
    <tradeName>Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81H160TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:00.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7G02E2</udiDi>
    <basicUdiDi>B-7G02E2</basicUdiDi>
    <tradeName>Cortisol assay (CLIA)</tradeName>
    <deviceName>Cortisol assay (CLIA)</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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7G02V1-B-EU, 7G02U1-B-EU, 7G02P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:23.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067131</udiDi>
    <basicUdiDi>69703416803205110J3</basicUdiDi>
    <tradeName>ALD (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060201</emdnCode>
    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511804</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:12:06.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067087</udiDi>
    <basicUdiDi>69703416803205110J3</basicUdiDi>
    <tradeName>ALD (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060201</emdnCode>
    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511803</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:12:06.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721543</udiDi>
    <basicUdiDi>692591270280HK</basicUdiDi>
    <tradeName>iFlash-AⅠ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86280-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721550</udiDi>
    <basicUdiDi>692591270293HU</basicUdiDi>
    <tradeName>iFlash-AⅡ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86281-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721567</udiDi>
    <basicUdiDi>692591270274HQ</basicUdiDi>
    <tradeName>iFlash-ALD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060201</emdnCode>
    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86283-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721581</udiDi>
    <basicUdiDi>692591270276HU</basicUdiDi>
    <tradeName>iFlash-Renin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86284-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723349</udiDi>
    <basicUdiDi>692591270045H7</basicUdiDi>
    <tradeName>iFlash-Cortisol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86034-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:09.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185400813</udiDi>
    <basicUdiDi>B-14562185400813</basicUdiDi>
    <tradeName>14562185400813</tradeName>
    <deviceName>CL AIA-PACK Cortisol SAMPLE DILUTING REAGENT</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029438</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:24.013Z</lastUpdated>
  </row>
</eudamedExport>