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<eudamedExport entity="devices">
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    <udiDi>03760173087372</udiDi>
    <basicUdiDi>376017308K1QX</basicUdiDi>
    <tradeName>KENZA ONE - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories</tradeName>
    <deviceName>KENZA ONE</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>KENZA ONE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:37.894Z</lastUpdated>
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  <row>
    <udiDi>03760173087259</udiDi>
    <basicUdiDi>376017308CLRT</basicUdiDi>
    <tradeName>EXTRA Cleaning</tradeName>
    <deviceName>Cleaning solution</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO4015</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:36.294Z</lastUpdated>
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  <row>
    <udiDi>03760173087228</udiDi>
    <basicUdiDi>376017308S1005N</basicUdiDi>
    <tradeName>SOLEA 100 - FULL AUTOMATED COAGULATION ANALYSER, including accessories</tradeName>
    <deviceName>SOLEA 100</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>SOLEA 100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:35.535Z</lastUpdated>
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  <row>
    <udiDi>03760173087204</udiDi>
    <basicUdiDi>376017308K4R5</basicUdiDi>
    <tradeName>KENZA 450TX - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories</tradeName>
    <deviceName>KENZA 450TX</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>KENZA 450TX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:33.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087181</udiDi>
    <basicUdiDi>376017308K2QZ</basicUdiDi>
    <tradeName>KENZA 240TX - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories</tradeName>
    <deviceName>KENZA 240TX</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>KENZA 240TX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:31.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087129</udiDi>
    <basicUdiDi>376017308BSS6</basicUdiDi>
    <tradeName>BIO SOLEA 2 - COAGULOMETER 2 CHANNELS, including accessories</tradeName>
    <deviceName>COAGULOMETER</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>BIOSOLEA 2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:29.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087006</udiDi>
    <basicUdiDi>376017308KMSM</basicUdiDi>
    <tradeName>KENZA MAX BioChemisTry PHOTOMETER</tradeName>
    <deviceName>KENZA MAX BioChemisTry PHOTOMETRE</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>KENZA MAX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:29.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173083060</udiDi>
    <basicUdiDi>376017308CACL22Q</basicUdiDi>
    <tradeName>CALCIUM CHLORIDE 0.025M</tradeName>
    <deviceName>CHLORURE DE CALCIUM 0,025M</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13565</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:27.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173083039</udiDi>
    <basicUdiDi>376017308OWKK7</basicUdiDi>
    <tradeName>OWREN KOLLER BUFFER</tradeName>
    <deviceName>OWREN KOLLER BUFFER</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020903</emdnCode>
    <emdnDescription>BUFFERS (HAEMOSTASIS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13883</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:25.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173080915</udiDi>
    <basicUdiDi>376017308NAOHB6</basicUdiDi>
    <tradeName>NaOH Solution 0.4 N</tradeName>
    <deviceName>Solution Soude 0,4 N</deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>92026</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:15:23.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087136</udiDi>
    <basicUdiDi>376017308BSS6</basicUdiDi>
    <tradeName>BIO SOLEA 4 - COAGULOMETER 4 CHANNELS, including accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>BIOSOLEA 4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:31.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087198</udiDi>
    <basicUdiDi>376017308K2QZ</basicUdiDi>
    <tradeName>KENZA 240ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, including accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>KENZA 240ISE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:31.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087211</udiDi>
    <basicUdiDi>376017308K4R5</basicUdiDi>
    <tradeName>KENZA 450ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, including accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>KENZA 450ISE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:31.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087266</udiDi>
    <basicUdiDi>376017308CLRT</basicUdiDi>
    <tradeName>IPO Cleaning</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO4020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:31.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087273</udiDi>
    <basicUdiDi>376017308K4R5</basicUdiDi>
    <tradeName>SERUM CUPS K450</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>CO0058</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:31.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087303</udiDi>
    <basicUdiDi>376017308CLRT</basicUdiDi>
    <tradeName>03760173087303</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2058/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:31.003Z</lastUpdated>
  </row>
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    <udiDi>03760173087365</udiDi>
    <basicUdiDi>376017308S1005N</basicUdiDi>
    <tradeName>CLEANING SOLUTION SOLEA 100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>S100CS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:30.979Z</lastUpdated>
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    <udiDi>03760173087389</udiDi>
    <basicUdiDi>376017308CLRT</basicUdiDi>
    <tradeName>Cleaning Solution for TIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:30.948Z</lastUpdated>
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  <row>
    <udiDi>03760173088270</udiDi>
    <basicUdiDi>376017308OWKK7</basicUdiDi>
    <tradeName>BE Owren Buffer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020903</emdnCode>
    <emdnDescription>BUFFERS (HAEMOSTASIS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>771700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:30.928Z</lastUpdated>
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  <row>
    <udiDi>03760173088287</udiDi>
    <basicUdiDi>376017308S1005N</basicUdiDi>
    <tradeName>BE Clean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</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>771800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:30.904Z</lastUpdated>
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