<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971354100279</udiDi>
    <basicUdiDi>B-06971354100279</basicUdiDi>
    <tradeName>ReLIA</tradeName>
    <deviceName>Anti-Mullerian Hormone Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>ReLIA Biotechnologies (Jiangsu), Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000042042</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RF16133-20T</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:52:06.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971225939762</udiDi>
    <basicUdiDi>B-06971225939762</basicUdiDi>
    <tradeName>Kemilo AMH Kit</tradeName>
    <deviceName>Kemilo AMH Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</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>KM32060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:31:06.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971225936310</udiDi>
    <basicUdiDi>B-06971225936310</basicUdiDi>
    <tradeName>FIA Go β-HCG Kit</tradeName>
    <deviceName>FIA Go β-HCG Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</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>FIA20025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:28:38.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971225935849</udiDi>
    <basicUdiDi>B-06971225935849</basicUdiDi>
    <tradeName>Kemilo TB-HCG Kit</tradeName>
    <deviceName>Kemilo TB-HCG Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM09018</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:28:12.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971225935832</udiDi>
    <basicUdiDi>B-06971225935832</basicUdiDi>
    <tradeName>Kemilo TB-HCG Kit</tradeName>
    <deviceName>Kemilo TB-HCG Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM09060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:28:12.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971225931308</udiDi>
    <basicUdiDi>B-06971225931308</basicUdiDi>
    <tradeName>FIA Go AMH Kit</tradeName>
    <deviceName>FIA Go AMH Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</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>FIA30025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:23:32.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-06934175046287QW</udiDi>
    <basicUdiDi>B-06934175046287QW</basicUdiDi>
    <tradeName>β-humanchorionic gonadotrophin</tradeName>
    <deviceName>β-Human Chorionic Gonadotropin Quantitative Test Kit (Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12600785</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:24:29.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>05206977000035</udiDi>
    <basicUdiDi>B-05206977000035</basicUdiDi>
    <tradeName>Self Clear</tradeName>
    <deviceName>Self Clear MK</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO-01-001M</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:29:19.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048017</udiDi>
    <basicUdiDi>69449040004H-E3********T3</basicUdiDi>
    <tradeName>Estriol (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050202</emdnCode>
    <emdnDescription>ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004253-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048314</udiDi>
    <basicUdiDi>69449040004H-HCG-II****HG</basicUdiDi>
    <tradeName>Total β HCG Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004290-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:29.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048383</udiDi>
    <basicUdiDi>69449040004H-E3********T3</basicUdiDi>
    <tradeName>Estriol Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004297-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:29.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325030206</udiDi>
    <basicUdiDi>B-04049325030206</basicUdiDi>
    <tradeName>Estrone ELISA</tradeName>
    <deviceName>Estrone ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB52051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:11:52.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325023031</udiDi>
    <basicUdiDi>B-04049325023031</basicUdiDi>
    <tradeName>Anti-Müllerian Hormone (AMH) ELISA</tradeName>
    <deviceName>Anti-Müllerian Hormone (AMH) ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30150318</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:11:47.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325009035</udiDi>
    <basicUdiDi>B-04049325009035</basicUdiDi>
    <tradeName>Estrone Saliva ELISA</tradeName>
    <deviceName>Estrone Saliva ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE52681</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:11:08.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325007710</udiDi>
    <basicUdiDi>B-04049325007710</basicUdiDi>
    <tradeName>PLGF ELISA</tradeName>
    <deviceName>PLGF ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE52361</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:10:56.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>03800502152019</udiDi>
    <basicUdiDi>B-03800502152019</basicUdiDi>
    <tradeName>Lepzi PLGF Test</tradeName>
    <deviceName>Lepzi PLGF Test</deviceName>
    <manufacturerName>Lepzi Diagnostika Ltd.</manufacturerName>
    <manufacturerSrn>BG-MF-000051504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD_BG002</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:36:45.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321418</udiDi>
    <basicUdiDi>B-03770024321418</basicUdiDi>
    <tradeName>RIA-gnost HCG</tradeName>
    <deviceName>OCPM03-HCG</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCPM03-HCG</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:32:28.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321166</udiDi>
    <basicUdiDi>B-03770024321166</basicUdiDi>
    <tradeName>03770024321166</tradeName>
    <deviceName>ELSA-FBHCG</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELSA-FBHCG</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:36.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760309511153</udiDi>
    <basicUdiDi>B-03760309511153</basicUdiDi>
    <tradeName>Toda Preterm Diag</tradeName>
    <deviceName>Toda Preterm Diag 1</deviceName>
    <manufacturerName>TODA PHARMA</manufacturerName>
    <manufacturerSrn>FR-MF-000007152</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21GO1-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:58:58.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760309511146</udiDi>
    <basicUdiDi>B-03760309511146</basicUdiDi>
    <tradeName>Toda Preterm Diag 10</tradeName>
    <deviceName>Toda Preterm Diag 10</deviceName>
    <manufacturerName>TODA PHARMA</manufacturerName>
    <manufacturerSrn>FR-MF-000007152</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21GO1-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:58:57.992Z</lastUpdated>
  </row>
</eudamedExport>