<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944904047805</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></emdnCode>
    <emdnDescription>ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004226-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:39.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047812</udiDi>
    <basicUdiDi>69449040004H-TESTO*****HB</basicUdiDi>
    <tradeName>Testosterone (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></emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004227-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:39.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047829</udiDi>
    <basicUdiDi>69449040AB74000055E</basicUdiDi>
    <tradeName>Progesterone（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></emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004228-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:39.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047836</udiDi>
    <basicUdiDi>69449040AB740000258</basicUdiDi>
    <tradeName>Free Triiodothyronine (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></emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004235-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:39.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047843</udiDi>
    <basicUdiDi>69449040004H-FT4*******QZ</basicUdiDi>
    <tradeName>Free Thyroxine (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></emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004236-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:39.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047850</udiDi>
    <basicUdiDi>69449040AB74000035A</basicUdiDi>
    <tradeName>Total Triiodothyronine (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></emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004237-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:39.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047867</udiDi>
    <basicUdiDi>69449040004H-T4********9G</basicUdiDi>
    <tradeName>Total Thyroxine (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></emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004238-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:39.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047874</udiDi>
    <basicUdiDi>69449040AB74000215C</basicUdiDi>
    <tradeName>Thyroid-Stimulating Hormone (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></emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004239-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:39.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047881</udiDi>
    <basicUdiDi>69449040004H-CEA*******JM</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen (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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004240-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:39.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047898</udiDi>
    <basicUdiDi>69449040AB74000225E</basicUdiDi>
    <tradeName>Alpha-fetoprotein (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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004241-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047904</udiDi>
    <basicUdiDi>69449040004H-CA125*****FK</basicUdiDi>
    <tradeName>Cancer Antigen 125 (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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004242-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047911</udiDi>
    <basicUdiDi>69449040004H-CA15-3****GZ</basicUdiDi>
    <tradeName>Cancer Antigen 15-3 (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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004243-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047928</udiDi>
    <basicUdiDi>69449040004H-CA19-9****M7</basicUdiDi>
    <tradeName>Carbohydrate Antigen 19-9 (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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004244-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047935</udiDi>
    <basicUdiDi>69449040AB740000156</basicUdiDi>
    <tradeName>Free Prostate Specific Antigen (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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004245-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047942</udiDi>
    <basicUdiDi>69449040004H-t-PSA*****H9</basicUdiDi>
    <tradeName>Total Prostate Specific Antigen(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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004246-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047959</udiDi>
    <basicUdiDi>69449040004H-FERR******L9</basicUdiDi>
    <tradeName>Ferritin (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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004247-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047973</udiDi>
    <basicUdiDi>69449040004H-FSH*******3N</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone (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></emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004249-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047980</udiDi>
    <basicUdiDi>69449040004H-LH********FV</basicUdiDi>
    <tradeName>Luteinizing Hormone (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></emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004250-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904047997</udiDi>
    <basicUdiDi>69449040004H-PRL*******ED</basicUdiDi>
    <tradeName>Prolactin (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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004251-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048000</udiDi>
    <basicUdiDi>69449040AB74000045C</basicUdiDi>
    <tradeName>Estradiol (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></emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004252-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.745Z</lastUpdated>
  </row>
</eudamedExport>