<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06979355924023</udiDi>
    <basicUdiDi>B-06979355924023</basicUdiDi>
    <tradeName>06979355924023</tradeName>
    <deviceName>Follicle stimulating hormone (FSH)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</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>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:17:00.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355924016</udiDi>
    <basicUdiDi>B-06979355924016</basicUdiDi>
    <tradeName>06979355924016</tradeName>
    <deviceName>Follicle stimulating hormone (FSH)  Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</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>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:16:59.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355921268</udiDi>
    <basicUdiDi>B-06979355921268</basicUdiDi>
    <tradeName>06979355921268</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (β-HCG) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:59.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355921251</udiDi>
    <basicUdiDi>B-06979355921251</basicUdiDi>
    <tradeName>06979355921251</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (β-HCG) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:57.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355921237</udiDi>
    <basicUdiDi>B-06979355921237</basicUdiDi>
    <tradeName>06979355921237</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (β-HCG) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:55.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355921220</udiDi>
    <basicUdiDi>B-06979355921220</basicUdiDi>
    <tradeName>06979355921220</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (β-HCG) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:55.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355921244</udiDi>
    <basicUdiDi>B-06979355921244</basicUdiDi>
    <tradeName>06979355921244</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (β-HCG) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:53.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979355921213</udiDi>
    <basicUdiDi>B-06979355921213</basicUdiDi>
    <tradeName>06979355921213</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin (β-HCG) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:39.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978945081351</udiDi>
    <basicUdiDi>B-06978945081351</basicUdiDi>
    <tradeName>Pregnancy-associated Plasma Protein A (CLIA)</tradeName>
    <deviceName>Pregnancy-associated Plasma Protein A (CLIA)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050210</emdnCode>
    <emdnDescription>PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1373B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:34.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978945081344</udiDi>
    <basicUdiDi>B-06978945081344</basicUdiDi>
    <tradeName>Pregnancy-associated Plasma Protein A (CLIA)</tradeName>
    <deviceName>Pregnancy-associated Plasma Protein A (CLIA)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050210</emdnCode>
    <emdnDescription>PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1373A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:33.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978945081115</udiDi>
    <basicUdiDi>B-06978945081115</basicUdiDi>
    <tradeName>Steroid Hormone Kit(LC-MS/MS)</tradeName>
    <deviceName>Steroid Hormone Kit(LC-MS/MS)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</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>LAZP906A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:56:53.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415830</udiDi>
    <basicUdiDi>B-06978896415830</basicUdiDi>
    <tradeName>06978896415830</tradeName>
    <deviceName>Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-AMH-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:16.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415823</udiDi>
    <basicUdiDi>B-06978896415823</basicUdiDi>
    <tradeName>06978896415823</tradeName>
    <deviceName>Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-AMH-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:15.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415816</udiDi>
    <basicUdiDi>B-06978896415816</basicUdiDi>
    <tradeName>06978896415816</tradeName>
    <deviceName>β Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-β-HCG-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:12.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415809</udiDi>
    <basicUdiDi>B-06978896415809</basicUdiDi>
    <tradeName>06978896415809</tradeName>
    <deviceName>β Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-β-HCG-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:11.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415779</udiDi>
    <basicUdiDi>B-06978896415779</basicUdiDi>
    <tradeName>06978896415779</tradeName>
    <deviceName>Luteinizing Hormone (LH) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-LH-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:06.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415762</udiDi>
    <basicUdiDi>B-06978896415762</basicUdiDi>
    <tradeName>06978896415762</tradeName>
    <deviceName>Luteinizing Hormone (LH) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-LH-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:04.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415731</udiDi>
    <basicUdiDi>B-06978896415731</basicUdiDi>
    <tradeName>06978896415731</tradeName>
    <deviceName>Estradiol (E2) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-E2-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:59.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415724</udiDi>
    <basicUdiDi>B-06978896415724</basicUdiDi>
    <tradeName>06978896415724</tradeName>
    <deviceName>Estradiol (E2) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-E2-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:58.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896415717</udiDi>
    <basicUdiDi>B-06978896415717</basicUdiDi>
    <tradeName>06978896415717</tradeName>
    <deviceName>Prolactin (PRL) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-PRL-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:57.408Z</lastUpdated>
  </row>
</eudamedExport>