<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03701700860396</udiDi>
    <basicUdiDi>37017008ProM-SeriesSL</basicUdiDi>
    <tradeName>Selectra ProM</tradeName>
    <deviceName>Selectra ProM</deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</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>6003-435</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:52:54.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700860549</udiDi>
    <basicUdiDi>37017008Mach-seriesPP</basicUdiDi>
    <tradeName>Selectra Mach5</tradeName>
    <deviceName>Selectra Mach5</deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</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>6004-301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:52:53.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700860327</udiDi>
    <basicUdiDi>37017008ProS-SeriesW6</basicUdiDi>
    <tradeName>Selectra ProS</tradeName>
    <deviceName>Selectra ProS</deviceName>
    <manufacturerName>VitalScientific B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000021018</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>6003-500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:52:48.226Z</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>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>04987666528559</udiDi>
    <basicUdiDi>150995901ZM062100GD</basicUdiDi>
    <tradeName>MICROPLATE TYPE P4 (12PCS/SET)</tradeName>
    <deviceName>MICROPLATE TYPE P4 (12PCS/SET)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZM062100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:27:27.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560161906918</udiDi>
    <basicUdiDi>0456016CA-310-NOISE9D</basicUdiDi>
    <tradeName>CA-310</tradeName>
    <deviceName>Clinical Chemistry Analyzer CA-310 without ISE</deviceName>
    <manufacturerName>Furuno Electric Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000026828</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>CA000002750</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:42:52.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560161906901</udiDi>
    <basicUdiDi>0456016CA-310-ISEMZ</basicUdiDi>
    <tradeName>CA-310</tradeName>
    <deviceName>Clinical Chemistry Analyzer CA-310 with ISE</deviceName>
    <manufacturerName>Furuno Electric Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000026828</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>CA000002750</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:42:51.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560161906895</udiDi>
    <basicUdiDi>0456016SENTiFIT9D</basicUdiDi>
    <tradeName>SENTiFIT 800</tradeName>
    <deviceName>SENTiFIT ®800 Analyzer</deviceName>
    <manufacturerName>Furuno Electric Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000026828</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>550800</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:42:50.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560161906871</udiDi>
    <basicUdiDi>0456016CA-800-NOISECD</basicUdiDi>
    <tradeName>CA-800</tradeName>
    <deviceName>Clinical Chemistry Analyzer CA-800 without ISE</deviceName>
    <manufacturerName>Furuno Electric Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000026828</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>CA000001551</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:42:50.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560161906864</udiDi>
    <basicUdiDi>0456016CA-800-ISEQ9</basicUdiDi>
    <tradeName>CA-800</tradeName>
    <deviceName>Clinical Chemistry Analyzer CA-800 with ISE</deviceName>
    <manufacturerName>Furuno Electric Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000026828</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>CA000001551</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:42:46.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560161906857</udiDi>
    <basicUdiDi>0456016CA-400-NOISE9H</basicUdiDi>
    <tradeName>CA-400</tradeName>
    <deviceName>Clinical Chemistry Analyzer CA-400 without ISE</deviceName>
    <manufacturerName>Furuno Electric Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000026828</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>CA000001475</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:42:45.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560161906840</udiDi>
    <basicUdiDi>0456016CA-400-ISEN5</basicUdiDi>
    <tradeName>CA-400</tradeName>
    <deviceName>Clinical Chemistry Analyzer CA-400 with ISE</deviceName>
    <manufacturerName>Furuno Electric Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000026828</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>CA000001475</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:42:44.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560161906833</udiDi>
    <basicUdiDi>0456016CA-270-NOISEC8</basicUdiDi>
    <tradeName>CA-270</tradeName>
    <deviceName>Clinical Chemistry Analyzer CA-270 without ISE</deviceName>
    <manufacturerName>Furuno Electric Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000026828</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>CA000001474</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:42:43.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560161906826</udiDi>
    <basicUdiDi>0456016CA-270-ISEPW</basicUdiDi>
    <tradeName>CA-270</tradeName>
    <deviceName>Clinical Chemistry Analyzer CA-270 with ISE</deviceName>
    <manufacturerName>Furuno Electric Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000026828</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>CA000001474</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:42:39.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145195641</udiDi>
    <basicUdiDi>04033145CC18974/2E7</basicUdiDi>
    <tradeName>Special Wash Solution-2</tradeName>
    <deviceName>Special Wash Solution-2</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18974/2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:27:35.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145192305</udiDi>
    <basicUdiDi>04033145CC18250DZ</basicUdiDi>
    <tradeName>HumaLyzer 4000</tradeName>
    <deviceName>HumaLyzer 4000</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</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>18250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:27:21.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145195634</udiDi>
    <basicUdiDi>04033145CC16663/11F3</basicUdiDi>
    <tradeName>Diluent-2</tradeName>
    <deviceName>Diluent-2</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16663/11</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:27:18.945Z</lastUpdated>
  </row>
</eudamedExport>