<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06977334213052</udiDi>
    <basicUdiDi>697733421RB01KG</basicUdiDi>
    <tradeName>YJSeq 300 Dx Sequencing System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055692</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCH-D SE075-D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:06.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977334213069</udiDi>
    <basicUdiDi>697733421RB01KG</basicUdiDi>
    <tradeName>YJSeq 300 Dx Sequencing System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055692</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCH 150cycles</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:06.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977334213076</udiDi>
    <basicUdiDi>697733421RB01KG</basicUdiDi>
    <tradeName>YJSeq 300 Dx Sequencing System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055692</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCH 300cycles</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:06.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977334213106</udiDi>
    <basicUdiDi>697733421RB01KG</basicUdiDi>
    <tradeName>YJSeq 300 Dx Sequencing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055692</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCP-D SE075-D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:06.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977334213113</udiDi>
    <basicUdiDi>697733421RB01KG</basicUdiDi>
    <tradeName>YJSeq 300 Dx Sequencing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055692</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCP 150cycles</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:06.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977334213120</udiDi>
    <basicUdiDi>697733421RB01KG</basicUdiDi>
    <tradeName>YJSeq 300 Dx Sequencing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055692</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCP 300cycles</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:57:06.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978704661138</udiDi>
    <basicUdiDi>6978704662200FM</basicUdiDi>
    <tradeName>06978704661138</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Acumen Biomedical Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038603</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:36:11.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978704661145</udiDi>
    <basicUdiDi>6978704662200FM</basicUdiDi>
    <tradeName>06978704661145</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Acumen Biomedical Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038603</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:36:11.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978704661152</udiDi>
    <basicUdiDi>6978704662200FM</basicUdiDi>
    <tradeName>06978704661152</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Acumen Biomedical Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038603</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220004-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:36:11.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978704661169</udiDi>
    <basicUdiDi>6978704662200FM</basicUdiDi>
    <tradeName>06978704661169</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Acumen Biomedical Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038603</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220004-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:36:11.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978704661176</udiDi>
    <basicUdiDi>6978704662200FM</basicUdiDi>
    <tradeName>06978704661176</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Acumen Biomedical Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038603</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220004-32</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:36:11.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978704661183</udiDi>
    <basicUdiDi>6978704662200FM</basicUdiDi>
    <tradeName>06978704661183</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Acumen Biomedical Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038603</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220015-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:36:11.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979502241478</udiDi>
    <basicUdiDi>697950224PCR1116016E</basicUdiDi>
    <tradeName>06979502241478</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR111601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:25:10.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940007690</udiDi>
    <basicUdiDi>081164701-GX-X5</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneXpert IV (GX-IV)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940007706</udiDi>
    <basicUdiDi>081164701-GX-X5</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneXpert XVI (GX-XVI)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940007720</udiDi>
    <basicUdiDi>081164701-INFINITY-ZH</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GX-INFINITY 80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940009687</udiDi>
    <basicUdiDi>081164701-GX-X5</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneXpert XVI-RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940009694</udiDi>
    <basicUdiDi>081164701-GX-X5</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneXpert IV (GX-IV)-RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>07622283013138</udiDi>
    <basicUdiDi>7622283ULPDx7A</basicUdiDi>
    <tradeName>07622283013138</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX6002UNICMDL30-32</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:11:06.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>07622283013145</udiDi>
    <basicUdiDi>7622283ULPDx7A</basicUdiDi>
    <tradeName>07622283013145</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX6002UNICMDL30-48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:11:06.884Z</lastUpdated>
  </row>
</eudamedExport>