<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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></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>06944904048024</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>105-004254-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048031</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>105-004255-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048086</udiDi>
    <basicUdiDi>69449040004H-RM-Con****NJ</basicUdiDi>
    <tradeName>Reproductive Multi Control</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>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004266-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048093</udiDi>
    <basicUdiDi>69449040004H-RM-Con****NJ</basicUdiDi>
    <tradeName>Reproductive Multi Control</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>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004267-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048147</udiDi>
    <basicUdiDi>69449040004H-RM-Con****NJ</basicUdiDi>
    <tradeName>Reproductive Multi Control</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>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004272-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:38.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048154</udiDi>
    <basicUdiDi>69449040004H-RM-Con****NJ</basicUdiDi>
    <tradeName>Reproductive Multi Control</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>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004273-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048161</udiDi>
    <basicUdiDi>69449040004H-Substrat**UD</basicUdiDi>
    <tradeName>Substrate Solution</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 A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004274-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048178</udiDi>
    <basicUdiDi>69449040004H-SampleD***T9</basicUdiDi>
    <tradeName>Sample Diluent</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 A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004276-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048185</udiDi>
    <basicUdiDi>69449040AB740000258</basicUdiDi>
    <tradeName>Free T3 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></emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004277-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048192</udiDi>
    <basicUdiDi>69449040004H-FT4*******QZ</basicUdiDi>
    <tradeName>Free T4 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></emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004278-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048208</udiDi>
    <basicUdiDi>69449040AB74000035A</basicUdiDi>
    <tradeName>Total T3 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></emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004279-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048215</udiDi>
    <basicUdiDi>69449040004H-T4********9G</basicUdiDi>
    <tradeName>Total T4 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></emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004280-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048222</udiDi>
    <basicUdiDi>69449040AB74000215C</basicUdiDi>
    <tradeName>TSH 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></emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004281-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048239</udiDi>
    <basicUdiDi>69449040004H-CEA*******JM</basicUdiDi>
    <tradeName>CEA 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004282-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048246</udiDi>
    <basicUdiDi>69449040AB74000225E</basicUdiDi>
    <tradeName>AFP 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004283-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048253</udiDi>
    <basicUdiDi>69449040004H-CA125*****FK</basicUdiDi>
    <tradeName>CA125 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004284-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048260</udiDi>
    <basicUdiDi>69449040004H-CA15-3****GZ</basicUdiDi>
    <tradeName>CA15-3 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004285-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048277</udiDi>
    <basicUdiDi>69449040004H-CA19-9****M7</basicUdiDi>
    <tradeName>CA19-9 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004286-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904048284</udiDi>
    <basicUdiDi>69449040AB740000156</basicUdiDi>
    <tradeName>Free PSA 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004287-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:30.088Z</lastUpdated>
  </row>
</eudamedExport>