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<eudamedExport entity="devices">
  <row>
    <udiDi>06976753471616</udiDi>
    <basicUdiDi>B-06976753471616</basicUdiDi>
    <tradeName>Progesterone (PROG) Assay Reagent Kit(CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KJ013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:57:06.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753471579</udiDi>
    <basicUdiDi>B-06976753471579</basicUdiDi>
    <tradeName>Follicle-Stimulating Hormone (FSH) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KJ012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:57:05.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753471531</udiDi>
    <basicUdiDi>B-06976753471531</basicUdiDi>
    <tradeName>Estradiol (E2) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</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>C2KJ011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:57:01.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753471418</udiDi>
    <basicUdiDi>B-06976753471418</basicUdiDi>
    <tradeName>Luteinizing Hormone (LH) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</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>C2KJ008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:56:59.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753471333</udiDi>
    <basicUdiDi>B-06976753471333</basicUdiDi>
    <tradeName>Dehydroepiandrosterone Sulfate (DHEA-S) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KJ006</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:56:55.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063805</udiDi>
    <basicUdiDi>B-06975984063805</basicUdiDi>
    <tradeName>PROG STAT (eCLIA)</tradeName>
    <deviceName>PROG STAT (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510604</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:20:08.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063782</udiDi>
    <basicUdiDi>B-06975984063782</basicUdiDi>
    <tradeName>PROG STAT (eCLIA)</tradeName>
    <deviceName>PROG STAT (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:20:06.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063263</udiDi>
    <basicUdiDi>B-06975984063263</basicUdiDi>
    <tradeName>Estradiol (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName>Estradiol (Electrochemiluminescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:18:23.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063256</udiDi>
    <basicUdiDi>B-06975984063256</basicUdiDi>
    <tradeName>Testosterone (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName>Testosterone (Electrochemiluminescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:18:19.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063249</udiDi>
    <basicUdiDi>B-06975984063249</basicUdiDi>
    <tradeName>Prolactin (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName>Prolactin (Electrochemiluminescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:18:18.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063232</udiDi>
    <basicUdiDi>B-06975984063232</basicUdiDi>
    <tradeName>Luteinizing Hormone (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName>Luteinizing Hormone (Electrochemiluminescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:18:17.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063218</udiDi>
    <basicUdiDi>B-06975984063218</basicUdiDi>
    <tradeName>Follicle-stimulating Hormone (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName>Follicle-stimulating Hormone (Electrochemiluminescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:18:12.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063140</udiDi>
    <basicUdiDi>B-06975984063140</basicUdiDi>
    <tradeName>Progesterone (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName>Progesterone (Electrochemiluminescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:18:04.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975679490756</udiDi>
    <basicUdiDi>B-06975679490756</basicUdiDi>
    <tradeName>PRL (Prolactin) Rapid Quantitative Test</tradeName>
    <deviceName>PRL (Prolactin) Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</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>PRL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:41:54.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975679490749</udiDi>
    <basicUdiDi>B-06975679490749</basicUdiDi>
    <tradeName>Progesterone Rapid Quantitative Test</tradeName>
    <deviceName>Progesterone Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Prog</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:41:38.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975679490367</udiDi>
    <basicUdiDi>B-06975679490367</basicUdiDi>
    <tradeName>Estradiol Rapid Quantitative Test</tradeName>
    <deviceName>Estradiol Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:41:03.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975456580298</udiDi>
    <basicUdiDi>B-06975456580298</basicUdiDi>
    <tradeName>BNIBT</tradeName>
    <deviceName>Progesterone Urine（PdG） Rapid Test</deviceName>
    <manufacturerName>Beijing North Institute of Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008259</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFPDGS-100</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:07.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975456580281</udiDi>
    <basicUdiDi>B-06975456580281</basicUdiDi>
    <tradeName>BNIBT</tradeName>
    <deviceName>Progesterone Urine（PdG） Rapid Test</deviceName>
    <manufacturerName>Beijing North Institute of Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008259</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFPDGS</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:06.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225909</udiDi>
    <basicUdiDi>B-06975424225909</basicUdiDi>
    <tradeName>Testosterone Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>Testosterone Assay Kit  (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247901C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:44:16.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225893</udiDi>
    <basicUdiDi>B-06975424225893</basicUdiDi>
    <tradeName>Progesterone Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>Progesterone Assay Kit  (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247801C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:44:15.825Z</lastUpdated>
  </row>
</eudamedExport>