<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03610230008447</udiDi>
    <basicUdiDi>B-03610230008447</basicUdiDi>
    <tradeName>Yumizen G DDi 2</tradeName>
    <deviceName>Yumizen G DDi 2</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036391</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:55.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008386</udiDi>
    <basicUdiDi>B-03610230008386</basicUdiDi>
    <tradeName>Yumizen G FIB 2</tradeName>
    <deviceName>Yumizen G FIB 2</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036383</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:51.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008379</udiDi>
    <basicUdiDi>B-03610230008379</basicUdiDi>
    <tradeName>Yumizen G TT</tradeName>
    <deviceName>Yumizen G TT</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036382</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:50.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008362</udiDi>
    <basicUdiDi>B-03610230008362</basicUdiDi>
    <tradeName>Yumizen G APTT Liq 2</tradeName>
    <deviceName>Yumizen G APTT Liq 2</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036379</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:50.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008355</udiDi>
    <basicUdiDi>B-03610230008355</basicUdiDi>
    <tradeName>Yumizen G APTT 4</tradeName>
    <deviceName>Yumizen G APTT 4</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036377</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:49.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008348</udiDi>
    <basicUdiDi>B-03610230008348</basicUdiDi>
    <tradeName>Yumizen G PT Reco 10</tradeName>
    <deviceName>Yumizen G PT Reco 10</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036376</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:45.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008331</udiDi>
    <basicUdiDi>B-03610230008331</basicUdiDi>
    <tradeName>Yumizen G PT Liq 4</tradeName>
    <deviceName>Yumizen G PT Liq 4</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036373</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:44.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008324</udiDi>
    <basicUdiDi>B-03610230008324</basicUdiDi>
    <tradeName>Yumizen G PT 5</tradeName>
    <deviceName>Yumizen G PT 5</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036338</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:43.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008232</udiDi>
    <basicUdiDi>B-03610230008232</basicUdiDi>
    <tradeName>ABX Pentra Micro ALB 2 Cal</tradeName>
    <deviceName>ABX Pentra Micro ALB 2 Cal</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300032565</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:42.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230008225</udiDi>
    <basicUdiDi>B-03610230008225</basicUdiDi>
    <tradeName>ABX Pentra Micro ALBUMIN 2 CP</tradeName>
    <deviceName>ABX Pentra Micro ALBUMIN 2 CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300032563</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:27.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230007884</udiDi>
    <basicUdiDi>B-03610230007884</basicUdiDi>
    <tradeName>Yumizen C Urine Level 2 Control</tradeName>
    <deviceName>Yumizen C Urine Level 2 Control</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300023947</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:26.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230007877</udiDi>
    <basicUdiDi>B-03610230007877</basicUdiDi>
    <tradeName>Yumizen C Urine Level 1 Control</tradeName>
    <deviceName>Yumizen C Urine Level 1 Control</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300023946</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:22.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230007105</udiDi>
    <basicUdiDi>B-03610230007105</basicUdiDi>
    <tradeName>Yumizen C1200 Lipase</tradeName>
    <deviceName>Yumizen C1200 Lipase</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300023858</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:21.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006795</udiDi>
    <basicUdiDi>B-03610230006795</basicUdiDi>
    <tradeName>ABX Pentra ASO 2 Cal</tradeName>
    <deviceName>ABX Pentra ASO 2 Cal</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152210</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300022600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:21.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006788</udiDi>
    <basicUdiDi>B-03610230006788</basicUdiDi>
    <tradeName>ABX Pentra ASO 2 CP</tradeName>
    <deviceName>ABX Pentra ASO 2 CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300022598</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:20.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006771</udiDi>
    <basicUdiDi>B-03610230006771</basicUdiDi>
    <tradeName>ABX Pentra Precitest Solution</tradeName>
    <deviceName>ABX Pentra Precitest Solution</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300017438</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:16.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005866</udiDi>
    <basicUdiDi>B-03610230005866</basicUdiDi>
    <tradeName>ABX Pentra Reference-E</tradeName>
    <deviceName>ABX Pentra Reference-E</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101070301</emdnCode>
    <emdnDescription>REFERENCE ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01741</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:15.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005859</udiDi>
    <basicUdiDi>B-03610230005859</basicUdiDi>
    <tradeName>ABX Pentra Potassium-E</tradeName>
    <deviceName>ABX Pentra Potassium-E</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101070106</emdnCode>
    <emdnDescription>POTASSIUM - ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01740</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:14.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005842</udiDi>
    <basicUdiDi>B-03610230005842</basicUdiDi>
    <tradeName>ABX Pentra Chloride-E</tradeName>
    <deviceName>ABX Pentra Chloride-E</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101070103</emdnCode>
    <emdnDescription>CHLORIDE - ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01739</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:13.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005835</udiDi>
    <basicUdiDi>B-03610230005835</basicUdiDi>
    <tradeName>ABX Pentra Sodium-E</tradeName>
    <deviceName>ABX Pentra Sodium-E</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101070107</emdnCode>
    <emdnDescription>SODIUM - ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01738</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:09.966Z</lastUpdated>
  </row>
</eudamedExport>