<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800111724091</udiDi>
    <basicUdiDi>88001117IPBA01IA34W8</basicUdiDi>
    <tradeName>STANDARD™ i Testosterone</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16TES10Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:53:56.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PRL706-AE9L</udiDi>
    <basicUdiDi>B-PRL706-AE9L</basicUdiDi>
    <tradeName>PRL Prolactin (CLIA)</tradeName>
    <deviceName>PRL Prolactin (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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRL706-AE10Y, PRL706-AE10N, PRL706-AE20Y, PRL706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T14:12:17.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PDG-A01aC7</udiDi>
    <basicUdiDi>B-PDG-A01aC7</basicUdiDi>
    <tradeName>PDG One Step Ovulation Test</tradeName>
    <deviceName>PDG One Step Ovulation Test</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>W0102050199</emdnCode>
    <emdnDescription>FERTILITY FUNCTION HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PDG-A01a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:42:31.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OVULATIONTEST3K</udiDi>
    <basicUdiDi>B-OVULATIONTEST3K</basicUdiDi>
    <tradeName>D-OVULATIONTEST3K</tradeName>
    <deviceName>Ovulation Test</deviceName>
    <manufacturerName>Sanavita Pharmaceuticals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OVULATIONTEST</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:37.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS12000P6</udiDi>
    <basicUdiDi>B-MS12000P6</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit for Steroids in Serum / Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050199</emdnCode>
    <emdnDescription>FERTILITY FUNCTION HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS12000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:27.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-LH706-AE47</udiDi>
    <basicUdiDi>B-LH706-AE47</basicUdiDi>
    <tradeName>LH Luteinizing Hormone (CLIA)</tradeName>
    <deviceName>LH Luteinizing 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>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LH706-AE10Y, LH706-AE10N, LH706-AE20Y, LH706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:49:21.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Testo-01100CJY</udiDi>
    <basicUdiDi>B-KR-Testo-01100CJY</basicUdiDi>
    <tradeName>INNODX Testo CMIA</tradeName>
    <deviceName>INNODX Testo CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-Testo-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:19.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-Prog-01100CRF</udiDi>
    <basicUdiDi>B-KR-Prog-01100CRF</basicUdiDi>
    <tradeName>INNODX Prog CMIA</tradeName>
    <deviceName>INNODX Prog CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-Prog-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:45:43.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-PRL-01100CBV</udiDi>
    <basicUdiDi>B-KR-PRL-01100CBV</basicUdiDi>
    <tradeName>INNODX PRL CMIA</tradeName>
    <deviceName>INNODX PRL CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-PRL-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:45:33.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-LH-01100CEZ</udiDi>
    <basicUdiDi>B-KR-LH-01100CEZ</basicUdiDi>
    <tradeName>INNODX LH CMIA</tradeName>
    <deviceName>INNODX LH CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-LH-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:44:16.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-FSH-01100CZ3</udiDi>
    <basicUdiDi>B-KR-FSH-01100CZ3</basicUdiDi>
    <tradeName>INNODX FSH CMIA</tradeName>
    <deviceName>INNODX FSH CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-FSH-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:48.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-E2-01100CVE</udiDi>
    <basicUdiDi>B-KR-E2-01100CVE</basicUdiDi>
    <tradeName>INNODX E2 CMIA</tradeName>
    <deviceName>INNODX E2 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-E2-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:42.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-045PK</udiDi>
    <basicUdiDi>B-K90411-045PK</basicUdiDi>
    <tradeName>D-K90411-045PK</tradeName>
    <deviceName>Sex hormone binding globulin (SHBG) Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050109</emdnCode>
    <emdnDescription>SEX HORMONE BINDING GLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:22.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-038PN</udiDi>
    <basicUdiDi>B-K90411-038PN</basicUdiDi>
    <tradeName>D-K90411-038PN</tradeName>
    <deviceName>Follicle stimulating hormone (FSH) Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:10.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-036PJ</udiDi>
    <basicUdiDi>B-K90411-036PJ</basicUdiDi>
    <tradeName>D-K90411-036PJ</tradeName>
    <deviceName>Luteinizing hormone (LH) Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:54.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-025PD</udiDi>
    <basicUdiDi>B-K90411-025PD</basicUdiDi>
    <tradeName>D-K90411-025PD</tradeName>
    <deviceName>Prolactin (PRL) Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:36.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-021P5</udiDi>
    <basicUdiDi>B-K90411-021P5</basicUdiDi>
    <tradeName>D-K90411-021P5</tradeName>
    <deviceName>Estradiol (E2) Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:30.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-019PJ</udiDi>
    <basicUdiDi>B-K90411-019PJ</basicUdiDi>
    <tradeName>D-K90411-019PJ</tradeName>
    <deviceName>Testosterone (TESTO) Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:28.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K42-SHBGYR</udiDi>
    <basicUdiDi>B-K42-SHBGYR</basicUdiDi>
    <tradeName>CrinoCheck SHBG</tradeName>
    <deviceName>SHBG  Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050109</emdnCode>
    <emdnDescription>SEX HORMONE BINDING GLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811023/K42-SHBG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:36:35.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K01220VY</udiDi>
    <basicUdiDi>B-K01220VY</basicUdiDi>
    <tradeName>D-K01220VY</tradeName>
    <deviceName>Free testosterone</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K01220</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:35:51.499Z</lastUpdated>
  </row>
</eudamedExport>