<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03610230009925</udiDi>
    <basicUdiDi>361023ymz_c560uric_acid7S</basicUdiDi>
    <tradeName>Yumizen C560 Uric Acid</tradeName>
    <deviceName>Yumizen C560 Uric Acid</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>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300141450</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:53.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009918</udiDi>
    <basicUdiDi>361023ymz_curic_acidA5</basicUdiDi>
    <tradeName>Yumizen C Uric Acid</tradeName>
    <deviceName>Yumizen C Uric Acid</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>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300141449</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:51.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009901</udiDi>
    <basicUdiDi>361023ymz_c560urea4N</basicUdiDi>
    <tradeName>Yumizen C560 Urea</tradeName>
    <deviceName>Yumizen C560 Urea</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>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300141448</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:50.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009895</udiDi>
    <basicUdiDi>361023ymz_cureaEC</basicUdiDi>
    <tradeName>Yumizen C Urea</tradeName>
    <deviceName>Yumizen C Urea</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>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300141447</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:46.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009864</udiDi>
    <basicUdiDi>361023ymz_c560glu_papCE</basicUdiDi>
    <tradeName>Yumizen C560 Glucose PAP</tradeName>
    <deviceName>Yumizen C560 Glucose PAP</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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300141444</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:43.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009857</udiDi>
    <basicUdiDi>361023ymz_cglucose_papMF</basicUdiDi>
    <tradeName>Yumizen C Glucose PAP</tradeName>
    <deviceName>Yumizen C Glucose PAP</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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300141443</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:41.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009840</udiDi>
    <basicUdiDi>361023ymz_c560glu_hkEZ</basicUdiDi>
    <tradeName>Yumizen C560 Glucose HK</tradeName>
    <deviceName>Yumizen C560 Glucose HK</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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300141442</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:39.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009833</udiDi>
    <basicUdiDi>361023ymz_cglucose_hkRT</basicUdiDi>
    <tradeName>Yumizen C Glucose HK</tradeName>
    <deviceName>Yumizen C Glucose HK</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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300141441</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:39.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009826</udiDi>
    <basicUdiDi>361023ymz_c560creat_jafWX</basicUdiDi>
    <tradeName>Yumizen C560 Creatinine Jaffé</tradeName>
    <deviceName>Yumizen C560 Creatinine Jaffé</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300141440</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:37.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009819</udiDi>
    <basicUdiDi>361023ymz_ccreat_jaffe5E</basicUdiDi>
    <tradeName>Yumizen C Creatinine Jaffé</tradeName>
    <deviceName>Yumizen C Creatinine Jaffé</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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300141429</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:32.611Z</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>03610230005736</udiDi>
    <basicUdiDi>361023pentra_creat120J3</basicUdiDi>
    <tradeName>ABX Pentra Creatinine 120 CP</tradeName>
    <deviceName>ABX Pentra Creatinine 120 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01933</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:12.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005231</udiDi>
    <basicUdiDi>361023pentra_uric_acidYJ</basicUdiDi>
    <tradeName>ABX Pentra Uric Acid CP</tradeName>
    <deviceName>ABX Pentra Uric Acid 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>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01670</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:05.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005217</udiDi>
    <basicUdiDi>361023pentra_glu_papRC</basicUdiDi>
    <tradeName>ABX Pentra Glucose PAP  CP</tradeName>
    <deviceName>ABX Pentra Glucose PAP CP</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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01668</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:04.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005200</udiDi>
    <basicUdiDi>361023pentra_glu_hkJ3</basicUdiDi>
    <tradeName>ABX Pentra Glucose HK CP</tradeName>
    <deviceName>ABX Pentra Glucose HK CP</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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01667</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:00.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005040</udiDi>
    <basicUdiDi>361023pentra_ureaSX</basicUdiDi>
    <tradeName>ABX Pentra Urea CP</tradeName>
    <deviceName>ABX Pentra Urea 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>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01641</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:14:59.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005033</udiDi>
    <basicUdiDi>361023pentra_triglyR5</basicUdiDi>
    <tradeName>ABX Pentra Triglycerides CP</tradeName>
    <deviceName>ABX Pentra Triglycerides 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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01640</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:14:58.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005019</udiDi>
    <basicUdiDi>361023pentra_ldl_dFF</basicUdiDi>
    <tradeName>ABX Pentra LDL Direct CP</tradeName>
    <deviceName>ABX Pentra LDL 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>W01010221</emdnCode>
    <emdnDescription>LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01638</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:14:54.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004999</udiDi>
    <basicUdiDi>361023pentra_hdl_directN8</basicUdiDi>
    <tradeName>ABX Pentra HDL Direct 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>A11A01636</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:14:52.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>03607360025154</udiDi>
    <basicUdiDi>3607362515BUCZ</basicUdiDi>
    <tradeName>CAPI 3 Hb A1c</tradeName>
    <deviceName>CAPI 3 Hb A1c</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2515</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:08:37.105Z</lastUpdated>
  </row>
</eudamedExport>