<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03610230008478</udiDi>
    <basicUdiDi>361023ymz_g_cleanerP2</basicUdiDi>
    <tradeName>Yumizen G CLEANER</tradeName>
    <deviceName>Yumizen G CLEANER</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>W0103020999</emdnCode>
    <emdnDescription>AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036420</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:03.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008461</udiDi>
    <basicUdiDi>361023ymz_g_sorbN7</basicUdiDi>
    <tradeName>Yumizen G SORB</tradeName>
    <deviceName>Yumizen G SORB</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>W0103020999</emdnCode>
    <emdnDescription>AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036418</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:58.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008317</udiDi>
    <basicUdiDi>361023ymz_g15x0QK</basicUdiDi>
    <tradeName>Yumizen G1550</tradeName>
    <deviceName>Yumizen G1500</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>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036331</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:58.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008201</udiDi>
    <basicUdiDi>361023ymz_h2500JX</basicUdiDi>
    <tradeName>Yumizen H2500 (Yumizen SPS connectable)</tradeName>
    <deviceName>Yumizen H2500</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300031326, 1300031327, 1300031328, 1300031329</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:57.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006719</udiDi>
    <basicUdiDi>361023sample_cup7S</basicUdiDi>
    <tradeName>SAMPLE CUP - GREEN</tradeName>
    <deviceName>SAMPLE CUP</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>W0503010280</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01766</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:56.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006689</udiDi>
    <basicUdiDi>361023pentra_c2006U</basicUdiDi>
    <tradeName>Pentra C200 Standard</tradeName>
    <deviceName>Pentra C200</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>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1280090005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:52.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006559</udiDi>
    <basicUdiDi>361023pentra_c40076</basicUdiDi>
    <tradeName>Pentra C400 ISE</tradeName>
    <deviceName>Pentra C400</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>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1280241013</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:51.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005743</udiDi>
    <basicUdiDi>361023pentra_hdl_directN8</basicUdiDi>
    <tradeName>ABX Pentra HDL Direct 100 CP</tradeName>
    <deviceName>ABX Pentra HDL Direct CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01934</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:51.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005552</udiDi>
    <basicUdiDi>361023pentra_clean_chemHQ</basicUdiDi>
    <tradeName>ABX Pentra Clean-Chem 99 CP</tradeName>
    <deviceName>ABX Pentra Clean-Chem CP</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01789</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:50.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008423</udiDi>
    <basicUdiDi>361023ymz_g_cal94</basicUdiDi>
    <tradeName>Yumizen G CAL</tradeName>
    <deviceName>Yumizen G CAL</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036416</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:41.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008416</udiDi>
    <basicUdiDi>361023ymz_g_contKF</basicUdiDi>
    <tradeName>Yumizen G CTRL I &amp; II</tradeName>
    <deviceName>Yumizen G CTRL I &amp; II</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036412</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:40.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008409</udiDi>
    <basicUdiDi>361023ymz_g_cacl2RT</basicUdiDi>
    <tradeName>Yumizen G CaCl2 4</tradeName>
    <deviceName>Yumizen G CaCl2 4</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>W0103020901</emdnCode>
    <emdnDescription>CALCIUM CHLORIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036386</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:39.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008393</udiDi>
    <basicUdiDi>361023ymz_g_imidazol3W</basicUdiDi>
    <tradeName>Yumizen G IMIDAZOL</tradeName>
    <deviceName>Yumizen G IMIDAZOL</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>W0103020999</emdnCode>
    <emdnDescription>AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036385</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:38.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008300</udiDi>
    <basicUdiDi>361023ymz_g15x0QK</basicUdiDi>
    <tradeName>Yumizen G1500</tradeName>
    <deviceName>Yumizen G1500</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>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036330</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:34.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008294</udiDi>
    <basicUdiDi>361023ymz_g800YQ</basicUdiDi>
    <tradeName>Yumizen G800</tradeName>
    <deviceName>Yumizen G800</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>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036318</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:33.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008287</udiDi>
    <basicUdiDi>361023ymz_g400Y4</basicUdiDi>
    <tradeName>Yumizen G400 DDi</tradeName>
    <deviceName>Yumizen G400 DDi</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>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036317</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:32.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008263</udiDi>
    <basicUdiDi>361023ymz_g200XS</basicUdiDi>
    <tradeName>Yumizen G200</tradeName>
    <deviceName>Yumizen G200</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>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036315</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:32.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008195</udiDi>
    <basicUdiDi>361023ymz_h2500JX</basicUdiDi>
    <tradeName>Yumizen H2500</tradeName>
    <deviceName>Yumizen H2500</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300031326, 1300031327, 1300031328, 1300031329</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:28.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008188</udiDi>
    <basicUdiDi>361023ymz_h1500JQ</basicUdiDi>
    <tradeName>Yumizen H1500</tradeName>
    <deviceName>Yumizen H1500</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300031324, 1300031325, 1300046881, 1300046884</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:27.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006702</udiDi>
    <basicUdiDi>361023sample_cup7S</basicUdiDi>
    <tradeName>SAMPLE CUP - BLUE</tradeName>
    <deviceName>SAMPLE CUP</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>W0503010280</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01765</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:26.480Z</lastUpdated>
  </row>
</eudamedExport>