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<eudamedExport entity="devices">
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    <udiDi>03701700819516</udiDi>
    <basicUdiDi>37017008CONT05AY</basicUdiDi>
    <tradeName>ELITROL II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONT-1160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:18.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700821618</udiDi>
    <basicUdiDi>37017008HLCA046J</basicUdiDi>
    <tradeName>HDL LDL CALIBRATOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLCA-4001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:16.518Z</lastUpdated>
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  <row>
    <udiDi>03701700823315</udiDi>
    <basicUdiDi>37017008IPRO04DS</basicUdiDi>
    <tradeName>PROTEIN IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPRO-4311</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:15.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700823322</udiDi>
    <basicUdiDi>37017008IPRO04DS</basicUdiDi>
    <tradeName>PROTEIN IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPRO-4312</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:15.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700823339</udiDi>
    <basicUdiDi>37017008IPRO04DS</basicUdiDi>
    <tradeName>PROTEIN IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPRO-4313</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:15.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700823346</udiDi>
    <basicUdiDi>37017008IPRO04DS</basicUdiDi>
    <tradeName>PROTEIN IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPRO-4314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:15.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700823353</udiDi>
    <basicUdiDi>37017008IPRO04DS</basicUdiDi>
    <tradeName>PROTEIN IP CALIBRATOR SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPRO-4315</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:15.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700824015</udiDi>
    <basicUdiDi>37017008ISCA049C</basicUdiDi>
    <tradeName>ISE CALIBRATORS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISCA-4221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:14.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700824022</udiDi>
    <basicUdiDi>37017008ISCA049C</basicUdiDi>
    <tradeName>ISE CALIBRATORS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISCA-4222</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:14.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901392</udiDi>
    <basicUdiDi>B-08800037901392</basicUdiDi>
    <tradeName>08800037901392</tradeName>
    <deviceName>SimplexTAS CRP Control Level 2</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0303002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:52.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901385</udiDi>
    <basicUdiDi>B-08800037901385</basicUdiDi>
    <tradeName>08800037901385</tradeName>
    <deviceName>SimplexTAS CRP Control Level 1</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0303001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:50.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901378</udiDi>
    <basicUdiDi>B-08800037901378</basicUdiDi>
    <tradeName>08800037901378</tradeName>
    <deviceName>SimplexTAS HbA1c Control Level 2</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0302002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:48.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901361</udiDi>
    <basicUdiDi>B-08800037901361</basicUdiDi>
    <tradeName>08800037901361</tradeName>
    <deviceName>SimplexTAS HbA1c Control Level 1</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0302001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:48.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901231</udiDi>
    <basicUdiDi>B-08800037901231</basicUdiDi>
    <tradeName>08800037901231</tradeName>
    <deviceName>SimplexTAS Chemistry Control Level 2</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0301002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:46.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901224</udiDi>
    <basicUdiDi>B-08800037901224</basicUdiDi>
    <tradeName>08800037901224</tradeName>
    <deviceName>SimplexTAS Chemistry Control Level 1</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050102</emdnCode>
    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0301001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:44.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698404547</udiDi>
    <basicUdiDi>B-06977698404547</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer（QC Solution 3）</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer（QC Solution 3）</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD076Q3</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:37:34.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698404486</udiDi>
    <basicUdiDi>B-06977698404486</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer（QC Solution 2）</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer（QC Solution 2）</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD076</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:37:33.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698404431</udiDi>
    <basicUdiDi>B-06977698404431</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer（QC Solution 1）</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer（QC Solution 1）</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD076Q1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:37:18.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698404325</udiDi>
    <basicUdiDi>B-06977698404325</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer（CO2 Standard Solution 2）</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer（CO2 Standard Solution 2）</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD07602</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:37:17.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698404264</udiDi>
    <basicUdiDi>B-06977698404264</basicUdiDi>
    <tradeName>Reagent for Electrolyte Analyzer（Standard Solution B）</tradeName>
    <deviceName>Reagent for Electrolyte Analyzer（Standard Solution B）</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD076B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:37:16.694Z</lastUpdated>
  </row>
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