<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>14562185400806</udiDi>
    <basicUdiDi>B-14562185400806</basicUdiDi>
    <tradeName>14562185400806</tradeName>
    <deviceName>CL AIA-PACK Cortisol ADJUSTER SET</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>0029238</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:23.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185400776</udiDi>
    <basicUdiDi>B-14562185400776</basicUdiDi>
    <tradeName>14562185400776</tradeName>
    <deviceName>CL AIA-PACK Cortisol TEST CUP</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>0029138</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:21.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189216164</udiDi>
    <basicUdiDi>B-14560189216164</basicUdiDi>
    <tradeName>14560189216164</tradeName>
    <deviceName>ST AIA-PACK CORTII</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>0025246</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:03:30.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189210735</udiDi>
    <basicUdiDi>B-14560189210735</basicUdiDi>
    <tradeName>14560189210735</tradeName>
    <deviceName>ST AIA-PACK CORT</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>0025287</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:01:54.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11J7W</udiDi>
    <basicUdiDi>B-11J7W</basicUdiDi>
    <tradeName>D-11J7W</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipocalin Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:25.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1180MCODS6K</udiDi>
    <basicUdiDi>B-1180MCODS6K</basicUdiDi>
    <tradeName>Cortisol &amp; Cortisone Dilute &amp; Shoot Reagent Set</tradeName>
    <deviceName>Cortisone &amp; Cortisol Dilute &amp; Shoot Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1180 M CODS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:10.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1100MSTPK7</udiDi>
    <basicUdiDi>B-1100MSTPK7</basicUdiDi>
    <tradeName>Steroid Basic Panel Reagent Set</tradeName>
    <deviceName>Steroid Basic Panel Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100 M STP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:47:09.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067155</udiDi>
    <basicUdiDi>69703416803205109JJ</basicUdiDi>
    <tradeName>Renin (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>W0102060204</emdnCode>
    <emdnDescription>RENINE (PLASMA RENINE ACTIVITY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:56:03.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067179</udiDi>
    <basicUdiDi>69703416803205109JJ</basicUdiDi>
    <tradeName>Renin (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>W0102060204</emdnCode>
    <emdnDescription>RENINE (PLASMA RENINE ACTIVITY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511902</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:55:54.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067162</udiDi>
    <basicUdiDi>69703416803205109JJ</basicUdiDi>
    <tradeName>Renin (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>W0102060204</emdnCode>
    <emdnDescription>RENINE (PLASMA RENINE ACTIVITY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511904</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:55:51.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145580636</udiDi>
    <basicUdiDi>694714551037J3</basicUdiDi>
    <tradeName>MAGLUMI Angiotensin I (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1302563005M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:45:00.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145580643</udiDi>
    <basicUdiDi>694714551037J3</basicUdiDi>
    <tradeName>MAGLUMI Angiotensin I (CLIA) Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011037MT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:58.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720514311714</udiDi>
    <basicUdiDi>B-08720514311714</basicUdiDi>
    <tradeName>Cortisol &amp; Cortisone Reagent Set</tradeName>
    <deviceName>Cortisol &amp; Cortisone Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1040 M CORT</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:16:04.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250933</udiDi>
    <basicUdiDi>B-08683548250933</basicUdiDi>
    <tradeName>RapidFor™ Cortisol Rapid Test Kit (FIA)</tradeName>
    <deviceName>Cortisol Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO55</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:11:00.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250377</udiDi>
    <basicUdiDi>B-08683548250377</basicUdiDi>
    <tradeName>RapidFor™ NGAL Rapid Test Kit (FIA)</tradeName>
    <deviceName>NGAL Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:49.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979878281535</udiDi>
    <basicUdiDi>B-06979878281535</basicUdiDi>
    <tradeName>06979878281535</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipocalin Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001053</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:37.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355927123</udiDi>
    <basicUdiDi>B-06979355927123</basicUdiDi>
    <tradeName>06979355927123</tradeName>
    <deviceName>Angiotensin II (Ang II) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit (including calibration and control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:28:20.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355927116</udiDi>
    <basicUdiDi>B-06979355927116</basicUdiDi>
    <tradeName>06979355927116</tradeName>
    <deviceName>Angiotensin II (Ang II) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit (including calibration and control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:28:00.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355927109</udiDi>
    <basicUdiDi>B-06979355927109</basicUdiDi>
    <tradeName>06979355927109</tradeName>
    <deviceName>Angiotensin II (Ang II) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit (including calibration and control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:28:00.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355927093</udiDi>
    <basicUdiDi>B-06979355927093</basicUdiDi>
    <tradeName>06979355927093</tradeName>
    <deviceName>Angiotensin II (Ang II) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit (including calibration and control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:27:59.284Z</lastUpdated>
  </row>
</eudamedExport>