<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-6-64AL</udiDi>
    <basicUdiDi>B-6-64AL</basicUdiDi>
    <tradeName>D-6-64AL</tradeName>
    <deviceName>Prolactin (PRL) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</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>"REF: USIA00000093M, USIA00000094M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:13:49.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDNOV03206</udiDi>
    <basicUdiDi>B-+ENTIDNOV03206</basicUdiDi>
    <tradeName>+ENTIDNOV03206</tradeName>
    <deviceName>Prolactin</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNOV032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:54.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111723452</udiDi>
    <basicUdiDi>88001117IPBA01IA13VY</basicUdiDi>
    <tradeName>STANDARD™ i Prolactin</tradeName>
    <deviceName>STANDARD™ i Prolactin</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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16PRL10D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:41:52.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID322U</udiDi>
    <basicUdiDi>B-VID322U</basicUdiDi>
    <tradeName>Prolactin Test Kit (FIA)</tradeName>
    <deviceName>Prolactin 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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID32-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:36.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-0947</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-0947</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-0947</tradeName>
    <deviceName>Prolactin 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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:40.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111723469</udiDi>
    <basicUdiDi>88001117IPBA01IA13VY</basicUdiDi>
    <tradeName>STANDARD™ i Prolactin</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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16PRL10F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:56:57.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111723476</udiDi>
    <basicUdiDi>88001117IPBA01IA13VY</basicUdiDi>
    <tradeName>STANDARD™ i Prolactin</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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16PRL10Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:56:56.300Z</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-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-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-IM4408203JQ</udiDi>
    <basicUdiDi>B-IM4408203JQ</basicUdiDi>
    <tradeName>D-IM4408203JQ</tradeName>
    <deviceName>PRL (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>IM4408203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:53.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407203JH</udiDi>
    <basicUdiDi>B-IM4407203JH</basicUdiDi>
    <tradeName>D-IM4407203JH</tradeName>
    <deviceName>PRL (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>IM4407203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:52.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406203JA</udiDi>
    <basicUdiDi>B-IM4406203JA</basicUdiDi>
    <tradeName>D-IM4406203JA</tradeName>
    <deviceName>PRL (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>IM4406203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:48.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4405203J3</udiDi>
    <basicUdiDi>B-IM4405203J3</basicUdiDi>
    <tradeName>D-IM4405203J3</tradeName>
    <deviceName>PRL (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>IM4405203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:24:48.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4404203HU</udiDi>
    <basicUdiDi>B-IM4404203HU</basicUdiDi>
    <tradeName>D-IM4404203HU</tradeName>
    <deviceName>PRL (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>IM4404203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:24:11.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403203HM</udiDi>
    <basicUdiDi>B-IM4403203HM</basicUdiDi>
    <tradeName>D-IM4403203HM</tradeName>
    <deviceName>PRL (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>IM4403203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:33.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402203HE</udiDi>
    <basicUdiDi>B-IM4402203HE</basicUdiDi>
    <tradeName>D-IM4402203HE</tradeName>
    <deviceName>PRL (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>IM4402203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:18:23.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4401203H7</udiDi>
    <basicUdiDi>B-IM4401203H7</basicUdiDi>
    <tradeName>D-IM4401203H7</tradeName>
    <deviceName>PRL (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>IM4401203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:16:21.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAPRL-402aHG8Y</udiDi>
    <basicUdiDi>B-FAPRL-402aHG8Y</basicUdiDi>
    <tradeName>PRL Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</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>FAPRL-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:22.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAPRL-402a6Y</udiDi>
    <basicUdiDi>B-FAPRL-402a6Y</basicUdiDi>
    <tradeName>PRL Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>PRL Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>FAPRL-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:21.848Z</lastUpdated>
  </row>
</eudamedExport>