<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00816270020637</udiDi>
    <basicUdiDi>0081627002NSQX2</basicUdiDi>
    <tradeName>NovaSeq™ 6000Dx Instrument</tradeName>
    <deviceName>NovaSeq™ 6000Dx Instrument</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20068232</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:54:05.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816270020125</udiDi>
    <basicUdiDi>0081627002NEXTSEQAD</basicUdiDi>
    <tradeName>NextSeq™ 550Dx Instrument</tradeName>
    <deviceName>NextSeq™ 550Dx Instrument</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20005715</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:37.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816270020002</udiDi>
    <basicUdiDi>0081627002MISEQQP</basicUdiDi>
    <tradeName>MiSeq™Dx Instrument</tradeName>
    <deviceName>MiSeq™Dx Instrument</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX-410-1001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:36.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816270020811</udiDi>
    <basicUdiDi>0081627002NEXTSEQAD</basicUdiDi>
    <tradeName>Illumina DRAGEN® Server for NextSeq550Dx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20086130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:57:47.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976019890090</udiDi>
    <basicUdiDi>697601989OY003PD</basicUdiDi>
    <tradeName>QPursue-6kDx Nanopore Sequencer</tradeName>
    <deviceName>QPursue-6kDx Nanopore Sequencer</deviceName>
    <manufacturerName>Qitan Taike Biotechnology Ltd., Chengdu</manufacturerName>
    <manufacturerSrn>CN-MF-000040515</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY003001</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:32.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976019890038</udiDi>
    <basicUdiDi>697601989OY001P9</basicUdiDi>
    <tradeName>QNome-3841 Nanopore Sequencer</tradeName>
    <deviceName>QNome-3841 Nanopore Sequencer</deviceName>
    <manufacturerName>Qitan Taike Biotechnology Ltd., Chengdu</manufacturerName>
    <manufacturerSrn>CN-MF-000040515</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY001001</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:31.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976019890021</udiDi>
    <basicUdiDi>697601989OY002PB</basicUdiDi>
    <tradeName>QNome-3841hexDx Nanopore Sequencer</tradeName>
    <deviceName>QNome-3841hexDx Nanopore Sequencer</deviceName>
    <manufacturerName>Qitan Taike Biotechnology Ltd., Chengdu</manufacturerName>
    <manufacturerSrn>CN-MF-000040515</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY002001</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:30.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975608185067</udiDi>
    <basicUdiDi>697560818model01F9</basicUdiDi>
    <tradeName>Sikun 2000</tradeName>
    <deviceName>Gene Sequencer</deviceName>
    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047921</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5067</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:22:42.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975102680013</udiDi>
    <basicUdiDi>697510268A001B2</basicUdiDi>
    <tradeName>06975102680013</tradeName>
    <deviceName>BJB Rapid Gene Detection System</deviceName>
    <manufacturerName>Jiangsu Bojia Biomedical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023653</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-1-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:09:29.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975102680020</udiDi>
    <basicUdiDi>697510268A001B2</basicUdiDi>
    <tradeName>06975102680020</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bojia Biomedical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023653</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-1-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:42.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975608185074</udiDi>
    <basicUdiDi>697560818model01F9</basicUdiDi>
    <tradeName>Sikun 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047921</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5074</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:27:20.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975608185081</udiDi>
    <basicUdiDi>697560818model01F9</basicUdiDi>
    <tradeName>Sikun 500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047921</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5081</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:27:20.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975608185098</udiDi>
    <basicUdiDi>697560818model01F9</basicUdiDi>
    <tradeName>Sikun 2000 Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047921</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5098</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:27:20.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975608185104</udiDi>
    <basicUdiDi>697560818model01F9</basicUdiDi>
    <tradeName>Sikun 1000 Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047921</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5104</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:27:20.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975608185111</udiDi>
    <basicUdiDi>697560818model01F9</basicUdiDi>
    <tradeName>Sikun 500 Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047921</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:27:20.307Z</lastUpdated>
  </row>
</eudamedExport>