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<eudamedExport entity="devices">
  <row>
    <udiDi>04580262016866</udiDi>
    <basicUdiDi>458026201RCRX</basicUdiDi>
    <tradeName>Reaction Cuvette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50-09-0262D</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:00:38.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262016002</udiDi>
    <basicUdiDi>458026201BIOLIS30i2W</basicUdiDi>
    <tradeName>BIOLIS 30i</tradeName>
    <deviceName>BIOLIS 30i</deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60-01-0001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:00:37.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262010321</udiDi>
    <basicUdiDi>458026201ISEWS9W</basicUdiDi>
    <tradeName>Cleaning Solution</tradeName>
    <deviceName>ISE Cleaner</deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-27-0479</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:00:37.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262010208</udiDi>
    <basicUdiDi>458026201WSTE</basicUdiDi>
    <tradeName>Alkaline Washing Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP2208</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:00:36.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262010222</udiDi>
    <basicUdiDi>458026201WSTE</basicUdiDi>
    <tradeName>Acid Washing Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP2209</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:29.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262020023</udiDi>
    <basicUdiDi>458026201RCRX</basicUdiDi>
    <tradeName>Cuvette-8U</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23-07-0055</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:29.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262020030</udiDi>
    <basicUdiDi>458026201RCRX</basicUdiDi>
    <tradeName>Cuvette-8U</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23-07-0055D</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:29.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262040151</udiDi>
    <basicUdiDi>458026201RCRX</basicUdiDi>
    <tradeName>Reaction Cuvette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50-09-0262</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:28.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262046511</udiDi>
    <basicUdiDi>458026201ISEWS9W</basicUdiDi>
    <tradeName>ISE Cleaner (1%)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50-27-0781</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:28.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262046528</udiDi>
    <basicUdiDi>458026201ISEWS9W</basicUdiDi>
    <tradeName>ISE Cleaner (5%)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50-27-0782</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:28.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262046818</udiDi>
    <basicUdiDi>458026201WSTE</basicUdiDi>
    <tradeName>Alkaline Washing Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50-24-0747</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:28.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262046825</udiDi>
    <basicUdiDi>458026201WSTE</basicUdiDi>
    <tradeName>Acid Washing Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50-24-0748</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:28.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262049840</udiDi>
    <basicUdiDi>458026201BIOLIS30i2W</basicUdiDi>
    <tradeName>SK300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>60-01-9005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:28.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262049857</udiDi>
    <basicUdiDi>458026201BIOLIS30i2W</basicUdiDi>
    <tradeName>TMS 30i</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>60-01-9006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:28.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262049871</udiDi>
    <basicUdiDi>458026201BIOLIS30i2W</basicUdiDi>
    <tradeName>Medisys 270</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>60-01-9008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:28.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>04580262049901</udiDi>
    <basicUdiDi>458026201BIOLIS30i2W</basicUdiDi>
    <tradeName>IMMTOX 270</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
    <manufacturerSrn>JP-MF-000025468</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>60-01-9011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:28.824Z</lastUpdated>
  </row>
</eudamedExport>