<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4499202MY</udiDi>
    <basicUdiDi>B-IM4499202MY</basicUdiDi>
    <tradeName>D-IM4499202MY</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4499202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:38:38.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4498202MR</udiDi>
    <basicUdiDi>B-IM4498202MR</basicUdiDi>
    <tradeName>D-IM4498202MR</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4498202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:38:32.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4497202MJ</udiDi>
    <basicUdiDi>B-IM4497202MJ</basicUdiDi>
    <tradeName>D-IM4497202MJ</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4497202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:38:23.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4496208MP</udiDi>
    <basicUdiDi>B-IM4496208MP</basicUdiDi>
    <tradeName>D-IM4496208MP</tradeName>
    <deviceName>Anti-Müllerian Hormone (AMH) Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4496208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:38:15.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4496202MB</udiDi>
    <basicUdiDi>B-IM4496202MB</basicUdiDi>
    <tradeName>D-IM4496202MB</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4496202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:38:13.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4495208MG</udiDi>
    <basicUdiDi>B-IM4495208MG</basicUdiDi>
    <tradeName>D-IM4495208MG</tradeName>
    <deviceName>Anti-Müllerian Hormone (AMH) Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4495208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:37:54.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4495202M4</udiDi>
    <basicUdiDi>B-IM4495202M4</basicUdiDi>
    <tradeName>D-IM4495202M4</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4495202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:37:51.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4494202LV</udiDi>
    <basicUdiDi>B-IM4494202LV</basicUdiDi>
    <tradeName>D-IM4494202LV</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4494202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:37:32.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4493208M2</udiDi>
    <basicUdiDi>B-IM4493208M2</basicUdiDi>
    <tradeName>D-IM4493208M2</tradeName>
    <deviceName>Anti-Müllerian Hormone (AMH) Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4493208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:37:10.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4493202LN</udiDi>
    <basicUdiDi>B-IM4493202LN</basicUdiDi>
    <tradeName>D-IM4493202LN</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4493202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:54.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4492208LT</udiDi>
    <basicUdiDi>B-IM4492208LT</basicUdiDi>
    <tradeName>D-IM4492208LT</tradeName>
    <deviceName>Anti-Müllerian Hormone (AMH) Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4492208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:29.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4492202LF</udiDi>
    <basicUdiDi>B-IM4492202LF</basicUdiDi>
    <tradeName>D-IM4492202LF</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4492202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:36:28.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4491208LL</udiDi>
    <basicUdiDi>B-IM4491208LL</basicUdiDi>
    <tradeName>D-IM4491208LL</tradeName>
    <deviceName>Anti-Müllerian Hormone (AMH) Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4491208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:50.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4491202L8</udiDi>
    <basicUdiDi>B-IM4491202L8</basicUdiDi>
    <tradeName>D-IM4491202L8</tradeName>
    <deviceName>Hormones Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4491202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:49.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HP147V3</udiDi>
    <basicUdiDi>B-HP147V3</basicUdiDi>
    <tradeName>TSH Control</tradeName>
    <deviceName>TSH Control</deviceName>
    <manufacturerName>Heavybio,Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000049958</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP147-1F, HP147-2F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:37.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HP123UM</udiDi>
    <basicUdiDi>B-HP123UM</basicUdiDi>
    <tradeName>T3 Control</tradeName>
    <deviceName>T3 Control</deviceName>
    <manufacturerName>Heavybio,Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000049958</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP123-1F, HP123-2F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:30.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKTT4-PN20HGQA</udiDi>
    <basicUdiDi>B-FKTT4-PN20HGQA</basicUdiDi>
    <tradeName>T4 Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKTT4-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:35:21.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKTT4-PN20FZ</udiDi>
    <basicUdiDi>B-FKTT4-PN20FZ</basicUdiDi>
    <tradeName>T4 Control</tradeName>
    <deviceName>T4 Control</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKTT4-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:35:20.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKTT3-PN20HGPP</udiDi>
    <basicUdiDi>B-FKTT3-PN20HGPP</basicUdiDi>
    <tradeName>T3 Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKTT3-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:35:14.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKTT3-PN20FL</udiDi>
    <basicUdiDi>B-FKTT3-PN20FL</basicUdiDi>
    <tradeName>T3 Control</tradeName>
    <deviceName>T3 Control</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKTT3-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:35:13.225Z</lastUpdated>
  </row>
</eudamedExport>