<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944904025018</udiDi>
    <basicUdiDi>694490400044PA*********TX</basicUdiDi>
    <tradeName>Prealbumin Kit（Turbidimetry Method）</tradeName>
    <deviceName>Prealbumin Kit (Turbidimetry Method)、Prealbumin Calibrator</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>IVDR 2017/746</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000845-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:33.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024998</udiDi>
    <basicUdiDi>694490400044IGM********K5</basicUdiDi>
    <tradeName>Immunoglobulin M Kit (Turbidimetry Method)</tradeName>
    <deviceName>Immunoglobulin M Kit (Turbidimetry Method)</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>IVDR 2017/746</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000843-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:18.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024974</udiDi>
    <basicUdiDi>694490400044CRP********RF</basicUdiDi>
    <tradeName>C-Reactive Protein Kit (Turbidimetry Method)</tradeName>
    <deviceName>C-Reactive Protein Kit (Turbidimetry Method)</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>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000841-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:17.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024943</udiDi>
    <basicUdiDi>694490400041ApoB*******B8</basicUdiDi>
    <tradeName>Apolipoprotein B Kit (Turbidimetry Method)</tradeName>
    <deviceName>Apolipoprotein B Kit (Turbidimetry Method)</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>IVDR 2017/746</legislation>
    <emdnCode>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000838-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:17.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024967</udiDi>
    <basicUdiDi>694490400044C4*********4G</basicUdiDi>
    <tradeName>Complement C4 Kit (Turbidimetry Method)</tradeName>
    <deviceName>Complement C4 Kit (Turbidimetry Method)</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>IVDR 2017/746</legislation>
    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000840-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:17.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904024936</udiDi>
    <basicUdiDi>694490400041ApoA1******EC</basicUdiDi>
    <tradeName>Apolipoprotein A1 Kit (Turbidimetry Method)</tradeName>
    <deviceName>Apolipoprotein A1 Kit (Turbidimetry Method)</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>IVDR 2017/746</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000837-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:12.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053158152</udiDi>
    <basicUdiDi>69449040004H-LH********FV</basicUdiDi>
    <tradeName>Luteinizing Hormone (CLIA)</tradeName>
    <deviceName>Luteinizing Hormone（CLIA）、LH Calibrators</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>IVDR 2017/746</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-064651-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:36:50.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053157766</udiDi>
    <basicUdiDi>69449040004H-PRL*******ED</basicUdiDi>
    <tradeName>Prolactin (CLIA)</tradeName>
    <deviceName>Prolactin (CLIA)、Prolactin Calibrators</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>IVDR 2017/746</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-064652-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:36:46.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053157780</udiDi>
    <basicUdiDi>69449040004H-FSH*******3N</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone (CLIA)</tradeName>
    <deviceName>Follicle Stimulating Hormone（CLIA）、FSH Calibrators</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>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-064648-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:36:46.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053157681</udiDi>
    <basicUdiDi>69449040004H-HCG-II****HG</basicUdiDi>
    <tradeName>Total β Human Chorionic Gonadotrophin (CLIA)</tradeName>
    <deviceName>Total β Human Chorionic Gonadotrophin（CLIA）、Total β HCG Calibrators</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>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-064647-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:36:45.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942253001226</udiDi>
    <basicUdiDi>69422530000013N7</basicUdiDi>
    <tradeName>AutoChem PA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Biochemistry Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038143</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>360101PA0000V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:30:50.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260211777</udiDi>
    <basicUdiDi>B-06933260211777</basicUdiDi>
    <tradeName>AMH Rapid Quantitative Test (Fluorescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT2213</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:36.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260212125</udiDi>
    <basicUdiDi>B-06933260212125</basicUdiDi>
    <tradeName>CRP/SAA Rapid Quantitative Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT2304</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:36.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802604816</udiDi>
    <basicUdiDi>69268026MD774A000018M</basicUdiDi>
    <tradeName>06926802604816</tradeName>
    <deviceName>Folate Release Reagent</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL11301E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:36.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802604403</udiDi>
    <basicUdiDi>69268026MD72C00001V3</basicUdiDi>
    <tradeName>06926802604403</tradeName>
    <deviceName>Anti-CCP (CLIA)</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MCL03601E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:29.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802603666</udiDi>
    <basicUdiDi>69268026MD71M00001YL</basicUdiDi>
    <tradeName>06926802603666</tradeName>
    <deviceName>Pre-Trigger Solution</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL01302E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:16.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802603642</udiDi>
    <basicUdiDi>69268026MD71N00001YZ</basicUdiDi>
    <tradeName>06926802603642</tradeName>
    <deviceName>Trigger Solution</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL01401E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:15.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802603635</udiDi>
    <basicUdiDi>69268026MD71W000014R</basicUdiDi>
    <tradeName>06926802603635</tradeName>
    <deviceName>Washing Buffer</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL02301E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:14.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802603611</udiDi>
    <basicUdiDi>69268026MD71L00001Y7</basicUdiDi>
    <tradeName>06926802603611</tradeName>
    <deviceName>Sample Diluent</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL01202E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:10.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926802603581</udiDi>
    <basicUdiDi>69268026MD71F00001VR</basicUdiDi>
    <tradeName>06926802603581</tradeName>
    <deviceName>PCT（CLIA）</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL02101E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:41:10.019Z</lastUpdated>
  </row>
</eudamedExport>