<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987562514304</udiDi>
    <basicUdiDi>4987562XF-1600TBNKSW37</basicUdiDi>
    <tradeName>04987562514304</tradeName>
    <deviceName>XF-1600 TBNK SW</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040192</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CB493081</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:59.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562509997</udiDi>
    <basicUdiDi>4987562XF-1600UZ</basicUdiDi>
    <tradeName>04987562509997</tradeName>
    <deviceName>Flow Cytometer XF-1600</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040192</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD629376</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:48.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562511921</udiDi>
    <basicUdiDi>4987562CyFlowWAUM</basicUdiDi>
    <tradeName>04987562511921</tradeName>
    <deviceName>CyFlow WA</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040192</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH647805</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:36:41.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590225889</udiDi>
    <basicUdiDi>150995902FlowCytometerRJ</basicUdiDi>
    <tradeName>AQUIOS CL Flow Cytometer</tradeName>
    <deviceName>Aquios Instrument</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040102</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - MODERATE ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B30166</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:34:12.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850037353675</udiDi>
    <basicUdiDi>0850037353ASLZK</basicUdiDi>
    <tradeName>Automated Sample Loader</tradeName>
    <deviceName>Automated Sample Loader</deviceName>
    <manufacturerName>Cytek Biosciences Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032048</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040180</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7-00044</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:23:03.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850037353637</udiDi>
    <basicUdiDi>0850037353NL-CLCSP</basicUdiDi>
    <tradeName>Northern Lights™-CLC</tradeName>
    <deviceName>Northern Lights™-CLC</deviceName>
    <manufacturerName>Cytek Biosciences Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032048</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040102</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - MODERATE ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7-00071</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:23:01.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850037353613</udiDi>
    <basicUdiDi>0850037353QCBEADS5E</basicUdiDi>
    <tradeName>SpectroFlo® QC Beads</tradeName>
    <deviceName>SpectroFlo® QC Beads</deviceName>
    <manufacturerName>Cytek Biosciences Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000032048</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040185</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B7-20002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:23:00.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436548983581</udiDi>
    <basicUdiDi>B-08436548983581</basicUdiDi>
    <tradeName>Infinicyt Basic CE-IVD</tradeName>
    <deviceName>Infinicyt Basic CE-IVD</deviceName>
    <manufacturerName>CYTOGNOS, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000000318</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202040182</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYT-INF-BASIC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:41:31.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436548983567</udiDi>
    <basicUdiDi>B-08436548983567</basicUdiDi>
    <tradeName>Infinicyt Advanced CE-IVD</tradeName>
    <deviceName>Infinicyt Advanced CE-IVD</deviceName>
    <manufacturerName>CYTOGNOS, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000000318</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202040182</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYT-INFINICYT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:41:30.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979824860012</udiDi>
    <basicUdiDi>697982486LSFSFC001EC</basicUdiDi>
    <tradeName>06979824860012</tradeName>
    <deviceName>Lymacyte Series Spectruml Flow Cytometers</deviceName>
    <manufacturerName>Shanghai Nokayun Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051537</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040101</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - LOW ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lymacyte（V-B-Y-R）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:45.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977908840004</udiDi>
    <basicUdiDi>69779088403003AR</basicUdiDi>
    <tradeName>FlowRACS</tradeName>
    <deviceName>High-throughput Raman-activated Flow Cytometer</deviceName>
    <manufacturerName>Qingdao Single-Cell Biotech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047609</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040101</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - LOW ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FlowRACS HT300 Univ</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:07:37.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975309200465</udiDi>
    <basicUdiDi>697530920G521E4</basicUdiDi>
    <tradeName>Flow Cytometer</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A2000A3</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:53.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975309200380</udiDi>
    <basicUdiDi>697530920038JU</basicUdiDi>
    <tradeName>06975309200380</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5101E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:52.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975309200373</udiDi>
    <basicUdiDi>697530920037JS</basicUdiDi>
    <tradeName>06975309200373</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5108E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:48.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975309200366</udiDi>
    <basicUdiDi>697530920036JQ</basicUdiDi>
    <tradeName>06975309200366</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5107E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:47.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975309200359</udiDi>
    <basicUdiDi>697530920035JN</basicUdiDi>
    <tradeName>06975309200359</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5106E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:46.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975309200342</udiDi>
    <basicUdiDi>697530920034JL</basicUdiDi>
    <tradeName>06975309200342</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5105E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:45.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975309200335</udiDi>
    <basicUdiDi>697530920033JJ</basicUdiDi>
    <tradeName>06975309200335</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5104E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:41.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975309200328</udiDi>
    <basicUdiDi>697530920032JG</basicUdiDi>
    <tradeName>06975309200328</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5103E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:40.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975309200304</udiDi>
    <basicUdiDi>697530920030JC</basicUdiDi>
    <tradeName>Flow Cytometer</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5004E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:40.112Z</lastUpdated>
  </row>
</eudamedExport>