<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00630414505152</udiDi>
    <basicUdiDi>0405686901823VW</basicUdiDi>
    <tradeName>ADVIA Centaur Total hCG</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_ThCG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10308984</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:07.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414290355</udiDi>
    <basicUdiDi>0405686902128VC</basicUdiDi>
    <tradeName>Atellica IM Placental Growth Factor (PlGF)</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Placental Growth Factor</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050211</emdnCode>
    <emdnDescription>PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11200232</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:49.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414015583</udiDi>
    <basicUdiDi>0405686902122UY</basicUdiDi>
    <tradeName>ADVIA Centaur Soluble fms-like Tyrosine Kinase-1 (sFlt-1)</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Soluble fms-like Tyrosine Kinase-1</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10997829</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:32:28.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414971698</udiDi>
    <basicUdiDi>0405686901473VR</basicUdiDi>
    <tradeName>IMMULITE 2000 Unconjugated Estriol</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_KIT_Unconjugated Estriol</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381171</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:57.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961835</udiDi>
    <basicUdiDi>0405686901458VV</basicUdiDi>
    <tradeName>IMMULITE 2000 PAPP-A</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_PAPP-A</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050210</emdnCode>
    <emdnDescription>PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381213</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:58.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961446</udiDi>
    <basicUdiDi>0405686901450VD</basicUdiDi>
    <tradeName>IMMULITE 2000 Free Beta HCG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_Free Beta HCG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381175</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:44.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Z033204R</udiDi>
    <basicUdiDi>B-Z033204R</basicUdiDi>
    <tradeName>D-Z033204R</tradeName>
    <deviceName>b-HCG</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>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z03320</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:12:28.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID5334</udiDi>
    <basicUdiDi>B-VID5334</basicUdiDi>
    <tradeName>Estrone-3-Glucuronide Test Kit (FIA)</tradeName>
    <deviceName>Estrone-3-Glucuronide Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID53-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:54.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID1934</udiDi>
    <basicUdiDi>B-VID1934</basicUdiDi>
    <tradeName>Beta Human Chorionic Gonadotropin Test Kit (FIA)</tradeName>
    <deviceName>Beta Human Chorionic Gonadotropin Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VID19-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:21:02.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID143EX</udiDi>
    <basicUdiDi>B-VID143EX</basicUdiDi>
    <tradeName>Pregnancy-Associated Plasma Protein A Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050210</emdnCode>
    <emdnDescription>PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID143-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:56.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID142EV</udiDi>
    <basicUdiDi>B-VID142EV</basicUdiDi>
    <tradeName>Estriol Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050202</emdnCode>
    <emdnDescription>ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID142-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:52.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID141ET</udiDi>
    <basicUdiDi>B-VID141ET</basicUdiDi>
    <tradeName>Free Beta Human Chorionic Gonadotrophin Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>VID141-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:50.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-3548</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-3548</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-3548</tradeName>
    <deviceName>PLGF &amp; sFLT-1 Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:37.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-313Y</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-313Y</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-313Y</tradeName>
    <deviceName>Human Chorionic Gonadotropin Beta-subunit Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</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>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:29.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-103Q</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-103Q</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-103Q</tradeName>
    <deviceName>Anti-Mullerian Hormone Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</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>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:40.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TB-HCG706-AEN4</udiDi>
    <basicUdiDi>B-TB-HCG706-AEN4</basicUdiDi>
    <tradeName>Total β-HCG Total β-Human Chorionic Gonadotropin (CLIA)</tradeName>
    <deviceName>Total β-HCG Total β-Human Chorionic Gonadotropin (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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-HCG706-AE10Y, TB-HCG706-AE10N, TB-HCG706-AE20Y, TB-HCG706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:54.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111724176</udiDi>
    <basicUdiDi>88001117IPBA01IA15W4</basicUdiDi>
    <tradeName>STANDARD™ i β-hCG</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>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16BHC10F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:42.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022033ED</udiDi>
    <basicUdiDi>B-SAC2022033ED</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Free β Human Chorionic Gonadotropin (F-β-HCG) Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</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>SAC2022033</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:53.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022032EB</udiDi>
    <basicUdiDi>B-SAC2022032EB</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Free β Human Chorionic Gonadotropin (F-β-HCG) Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</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>SAC2022032</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:49.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022031E9</udiDi>
    <basicUdiDi>B-SAC2022031E9</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Free β Human Chorionic Gonadotropin (F-β-HCG) Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</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>SAC2022031</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:49.657Z</lastUpdated>
  </row>
</eudamedExport>