<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06903053021067</udiDi>
    <basicUdiDi>69449040004W-CMVIgM****8F</basicUdiDi>
    <tradeName>Cytomegalovirus IgM (CLIA)</tradeName>
    <deviceName>Cytomegalovirus IgM (CLIA)</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>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012543-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:45.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053021043</udiDi>
    <basicUdiDi>69449040004W-RVIgM*****DU</basicUdiDi>
    <tradeName>Rubella Virus IgM (CLIA)</tradeName>
    <deviceName>Rubella Virus IgM (CLIA)</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>W0105040103</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012513-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:45.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053020909</udiDi>
    <basicUdiDi>69449040004W-RVIgG*****BE</basicUdiDi>
    <tradeName>Rubella Virus IgG (CLIA)</tradeName>
    <deviceName>Rubella Virus IgG (CLIA)</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>W0105040102</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012522-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:39.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260212446</udiDi>
    <basicUdiDi>B-06933260212446</basicUdiDi>
    <tradeName>Virus RNA Collection Kit</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>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:36.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260212460</udiDi>
    <basicUdiDi>B-06933260212460</basicUdiDi>
    <tradeName>Novel Coronavirus (SARSCoV-2) Real Time Multiplex RT-PCR Kit</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>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:36.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720027</udiDi>
    <basicUdiDi>692591270255HL</basicUdiDi>
    <tradeName>iFlash-EB EA IgG</tradeName>
    <deviceName>iFlash-EB EA IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W010504040108</emdnCode>
    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86141G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:51.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719168</udiDi>
    <basicUdiDi>692591270084HH</basicUdiDi>
    <tradeName>iFlash-EB EA IgM</tradeName>
    <deviceName>iFlash-EB EA IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W010504040107</emdnCode>
    <emdnDescription>EBV EA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88009M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:05.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715931</udiDi>
    <basicUdiDi>692591270103GU</basicUdiDi>
    <tradeName>iFlash-CMV IgG</tradeName>
    <deviceName>iFlash-CMV IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040203</emdnCode>
    <emdnDescription>CMV IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88032G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:35.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715719</udiDi>
    <basicUdiDi>692591270083HF</basicUdiDi>
    <tradeName>iFlash-EB NA IgG</tradeName>
    <deviceName>iFlash-EB NA IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88008G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:24.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715733</udiDi>
    <basicUdiDi>692591270085HK</basicUdiDi>
    <tradeName>iFlash-EB VCA IgA</tradeName>
    <deviceName>iFlash-EB VCA IgA</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88011A-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:23.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715740</udiDi>
    <basicUdiDi>692591270086HM</basicUdiDi>
    <tradeName>iFlash-EB NA IgA</tradeName>
    <deviceName>iFlash-EB NA IgA</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88012A-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:22.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715702</udiDi>
    <basicUdiDi>692591270082HD</basicUdiDi>
    <tradeName>iFlash-EB VCA IgM</tradeName>
    <deviceName>iFlash-EB VCA IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W010504040104</emdnCode>
    <emdnDescription>EBV VCA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88007M-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:19.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715696</udiDi>
    <basicUdiDi>692591270081HB</basicUdiDi>
    <tradeName>iFlash-EB VCA IgG</tradeName>
    <deviceName>iFlash-EB VCA IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88006G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:19.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715689</udiDi>
    <basicUdiDi>692591270106H2</basicUdiDi>
    <tradeName>iFlash-Rubella IgM</tradeName>
    <deviceName>iFlash-Rubella IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040103</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88036M-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:19.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715672</udiDi>
    <basicUdiDi>692591270105GY</basicUdiDi>
    <tradeName>iFlash-Rubella IgG</tradeName>
    <deviceName>iFlash-Rubella IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040102</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88035G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:13.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715665</udiDi>
    <basicUdiDi>692591270104GW</basicUdiDi>
    <tradeName>iFlash-CMV IgM</tradeName>
    <deviceName>iFlash-CMV IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88033M-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:09.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715597</udiDi>
    <basicUdiDi>692591270062H7</basicUdiDi>
    <tradeName>iFlash-HSV-1 IgM</tradeName>
    <deviceName>iFlash-HSV-1 IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040307</emdnCode>
    <emdnDescription>HSV 1 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88041M-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:07.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715580</udiDi>
    <basicUdiDi>692591270060H3</basicUdiDi>
    <tradeName>iFlash-HSV-2 IgM</tradeName>
    <deviceName>iFlash-HSV-2 IgM</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040310</emdnCode>
    <emdnDescription>HSV 2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88039M-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:29:52.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715573</udiDi>
    <basicUdiDi>692591270059HJ</basicUdiDi>
    <tradeName>iFlash-HSV-2 IgG</tradeName>
    <deviceName>iFlash-HSV-2 IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88038G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:29:51.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715344</udiDi>
    <basicUdiDi>692591270061H5</basicUdiDi>
    <tradeName>iFlash-HSV-1 IgG</tradeName>
    <deviceName>iFlash-HSV-1 IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</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>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88040G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:29:26.085Z</lastUpdated>
  </row>
</eudamedExport>