<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03610230004432</udiDi>
    <basicUdiDi>361023eosinofix3H</basicUdiDi>
    <tradeName>ABX Eosinofix 1L</tradeName>
    <deviceName>ABX Eosinofix 1L</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0206010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:12:03.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004425</udiDi>
    <basicUdiDi>361023basolyse_5LC8</basicUdiDi>
    <tradeName>ABX Basolyse 5L</tradeName>
    <deviceName>ABX Basolyse 5L</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0204050</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:12:02.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987562509079</udiDi>
    <basicUdiDi>4987562STROMATOLYSER4DLCC</basicUdiDi>
    <tradeName>STROMATOLYSER-4DL</tradeName>
    <deviceName>STROMATOLYSER -4DL</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>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>054-3321-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:43:01.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>B787TK10</udiDi>
    <basicUdiDi>B-B787TK10</basicUdiDi>
    <tradeName>Sight OLO CBC Test Kit</tradeName>
    <deviceName>Sight OLO CBC Test Kit</deviceName>
    <manufacturerName>S.D. Sight Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000026216</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>TK1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:54:13.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975838800914</udiDi>
    <basicUdiDi>B-06975838800914</basicUdiDi>
    <tradeName>CBC Assay Kit</tradeName>
    <deviceName>CBC Assay Kit</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE50101</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:12:33.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175049820</udiDi>
    <basicUdiDi>6934175002B0030NY</basicUdiDi>
    <tradeName>Hematology Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12600777</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:47:59.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941377306460</udiDi>
    <basicUdiDi>697049309W01030000028AC</basicUdiDi>
    <tradeName>Hematology Analysis Reagent Kit</tradeName>
    <deviceName>Hematology Analysis Reagent Kit</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PO-0030-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:27:01.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595746327</udiDi>
    <basicUdiDi>693659579012PE</basicUdiDi>
    <tradeName>Automated Hematology Analyzer Lyse</tradeName>
    <deviceName>Automated Hematology Analyzer Lyse</deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ9012Y</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:09:13.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595746303</udiDi>
    <basicUdiDi>693659579013PG</basicUdiDi>
    <tradeName>Automated Hematology Analyzer Lyse</tradeName>
    <deviceName>Automated Hematology Analyzer Lyse</deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ9013Y</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:09:12.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595746297</udiDi>
    <basicUdiDi>693659579014PJ</basicUdiDi>
    <tradeName>Automated Hematology Analyzer Diluent</tradeName>
    <deviceName>Automated Hematology Analyzer Diluent</deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ9014Y</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:09:11.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004579</udiDi>
    <basicUdiDi>361023minidil_lmgGN</basicUdiDi>
    <tradeName>ABX Minidil LMG 20L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0802020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004609</udiDi>
    <basicUdiDi>361023diluentG8</basicUdiDi>
    <tradeName>ABX Diluent 20L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0901020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004616</udiDi>
    <basicUdiDi>361023cleanerAK</basicUdiDi>
    <tradeName>ABX Cleaner 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0903010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004623</udiDi>
    <basicUdiDi>361023cleanerAK</basicUdiDi>
    <tradeName>ABX Cleaner 0.5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0903011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004661</udiDi>
    <basicUdiDi>361023lyseX2</basicUdiDi>
    <tradeName>ABX Alphalyse 0.4L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0906004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004692</udiDi>
    <basicUdiDi>361023lysebioQM</basicUdiDi>
    <tradeName>ABX Lysebio 0.4L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0906013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004708</udiDi>
    <basicUdiDi>361023lyseX2</basicUdiDi>
    <tradeName>ABX Alphalyse 360mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0906014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987562509109</udiDi>
    <basicUdiDi>4987562STROMATOLYSERWHPH</basicUdiDi>
    <tradeName>STROMATOLYSER-WH</tradeName>
    <deviceName>STROMATOLYSER-WH</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>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>974-0521-6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:13:02.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987562509086</udiDi>
    <basicUdiDi>4987562STROMATOLYSER4DSCS</basicUdiDi>
    <tradeName>STROMATOLYSER-4DS</tradeName>
    <deviceName>STROMATOLYSER-4DS</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>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>054-3331-0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:13:01.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987562509024</udiDi>
    <basicUdiDi>4987562FluorocellWPCVL</basicUdiDi>
    <tradeName>14987562509024</tradeName>
    <deviceName>Fluorocell WPC</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>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE228898</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:25.755Z</lastUpdated>
  </row>
</eudamedExport>