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<eudamedExport entity="devices">
  <row>
    <udiDi>03610230006672</udiDi>
    <basicUdiDi>361023pentra_c2006U</basicUdiDi>
    <tradeName>Pentra C200 ISE</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>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1280090002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:25.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006542</udiDi>
    <basicUdiDi>361023pentra_c40076</basicUdiDi>
    <tradeName>Pentra C400 Standard</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>W0201010102</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1280241012</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:20.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006405</udiDi>
    <basicUdiDi>361023pentra_xlrEA</basicUdiDi>
    <tradeName>Pentra XLR</tradeName>
    <deviceName>Pentra XLR</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1280110003, 1280110005, 1280110007, 1280110009, 1280110011, 1280110013,1280110015, 1280110016, 1300039852, 1300039853</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:20.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006399</udiDi>
    <basicUdiDi>361023pentra_xl80LB</basicUdiDi>
    <tradeName>ABX Pentra XL80</tradeName>
    <deviceName>ABX Pentra XL80</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1280110025, 1280110027, 1280110029,1280110031,1280110033, 1280110035, 1280110036, 1280110038, 1300039850, 1300039851</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:19.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005873</udiDi>
    <basicUdiDi>361023pentra_dummy_eU5</basicUdiDi>
    <tradeName>ABX Pentra Dummy-E</tradeName>
    <deviceName>ABX Pentra Dummy-E</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>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01851</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:18.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005798</udiDi>
    <basicUdiDi>361023pentra_ise_cleanQS</basicUdiDi>
    <tradeName>ABX Pentra ISE Cleaner CP</tradeName>
    <deviceName>ABX Pentra ISE Cleaner 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>W0101070399</emdnCode>
    <emdnDescription>REFERENCE MATERIALS AND BUFFERS (ELECTROLYTES) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01971</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:14.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005750</udiDi>
    <basicUdiDi>361023pentra_calcium_asM6</basicUdiDi>
    <tradeName>ABX Pentra Calcium AS CP</tradeName>
    <deviceName>ABX Pentra Calcium AS 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>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01954</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:13.693Z</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>03610230005514</udiDi>
    <basicUdiDi>361023pentra_etchingNN</basicUdiDi>
    <tradeName>ABX Pentra Etching CP</tradeName>
    <deviceName>ABX Pentra Etching 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>A11A01769</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:12.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005491</udiDi>
    <basicUdiDi>361023pentra_clean_chemHQ</basicUdiDi>
    <tradeName>ABX Pentra Clean-Chem 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>A11A01755</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:07.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230005484</udiDi>
    <basicUdiDi>361023pentra_deprotHD</basicUdiDi>
    <tradeName>ABX Pentra Deproteinizer CP</tradeName>
    <deviceName>ABX Pentra Deproteinizer 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>A11A01754</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:06.512Z</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>03610230005194</udiDi>
    <basicUdiDi>361023pentra_phosphorusKU</basicUdiDi>
    <tradeName>ABX Pentra Phosphorus CP</tradeName>
    <deviceName>ABX Pentra Phosphorus 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>W01010307</emdnCode>
    <emdnDescription>PHOSPHATE INORGANIC / PHOSPHORUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01665</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:00.065Z</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>03610230004852</udiDi>
    <basicUdiDi>361023pentra_ferr_calZS</basicUdiDi>
    <tradeName>ABX Pentra Ferritin Cal</tradeName>
    <deviceName>ABX Pentra Ferritin Cal</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01619</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:14:52.082Z</lastUpdated>
  </row>
</eudamedExport>