<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974318133771</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCS PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-003025-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:46:22.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974318133801</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCS SE100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-003026-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:46:21.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974318133788</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T1+ App-D FCS SE100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-003026-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:46:21.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469761774</udiDi>
    <basicUdiDi>6973315738996CC</basicUdiDi>
    <tradeName>VAHTS DNA Library Prep Kit for MGI</tradeName>
    <deviceName>VAHTS DNA Library Prep Kit for MGI</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDMB609ME-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:40:13.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469761750</udiDi>
    <basicUdiDi>6973315736343AB</basicUdiDi>
    <tradeName>VAHTS DNA Library Prep Kit for Illumina</tradeName>
    <deviceName>VAHTS DNA Library Prep Kit for Illumina</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDB609ME-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:40:09.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469761767</udiDi>
    <basicUdiDi>6973315736343AB</basicUdiDi>
    <tradeName>VAHTS DNA Library Prep Kit for Illumina</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDB609ME-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T04:38:42.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469761781</udiDi>
    <basicUdiDi>6973315738996CC</basicUdiDi>
    <tradeName>VAHTS DNA Library Prep Kit for MGI</tradeName>
    <deviceName>VAHTS DNA Library Prep Kit for MGI</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDMB609ME-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:14:28.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042912</udiDi>
    <basicUdiDi>697478304MFG0101063W</basicUdiDi>
    <tradeName>06974783042912</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010106</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:07:06.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042851</udiDi>
    <basicUdiDi>697478304MFG0100343W</basicUdiDi>
    <tradeName>06974783042851</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010034</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:07:02.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042837</udiDi>
    <basicUdiDi>697478304MFG0100333U</basicUdiDi>
    <tradeName>06974783042837</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010033</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:07:02.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042899</udiDi>
    <basicUdiDi>697478304MFG01010944</basicUdiDi>
    <tradeName>06974783042899</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010109</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:07:01.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042875</udiDi>
    <basicUdiDi>697478304MFG01010842</basicUdiDi>
    <tradeName>06974783042875</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010108</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:07:00.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042813</udiDi>
    <basicUdiDi>697478304MFG01001942</basicUdiDi>
    <tradeName>06974783042813</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010019</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:06:42.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042776</udiDi>
    <basicUdiDi>697478304MFG0101053U</basicUdiDi>
    <tradeName>06974783042776</tradeName>
    <deviceName>Nucleic Acid Extraction Kit Pro</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010105</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:06:41.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042752</udiDi>
    <basicUdiDi>697478304MFG0100874K</basicUdiDi>
    <tradeName>06974783042752</tradeName>
    <deviceName>Nucleic Acid Extraction Kit Pro</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010087</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:06:41.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042738</udiDi>
    <basicUdiDi>697478304MFG0100113J</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Kit</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010011</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:06:40.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042714</udiDi>
    <basicUdiDi>697478304MFG0101043S</basicUdiDi>
    <tradeName>06974783042714</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010104</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:06:36.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042745</udiDi>
    <basicUdiDi>697478304MFG0100113J</basicUdiDi>
    <tradeName>06974783042745</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:53:28.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042721</udiDi>
    <basicUdiDi>697478304MFG0101043S</basicUdiDi>
    <tradeName>06974783042721</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010104</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:53:27.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042769</udiDi>
    <basicUdiDi>697478304MFG0100874K</basicUdiDi>
    <tradeName>06974783042769</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010087</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:53:02.268Z</lastUpdated>
  </row>
</eudamedExport>