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<eudamedExport entity="devices">
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    <udiDi>00816426020825</udiDi>
    <basicUdiDi>B-00816426020825</basicUdiDi>
    <tradeName>K-ASSAY Liquid ITA Control</tradeName>
    <deviceName>Liquid ITA Control</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K49C-4M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:00.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020795</udiDi>
    <basicUdiDi>B-00816426020795</basicUdiDi>
    <tradeName>K-ASSAY Microalbumin Urine Control</tradeName>
    <deviceName>Microalbumin Urine Control</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K37C-4M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:59.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020771</udiDi>
    <basicUdiDi>B-00816426020771</basicUdiDi>
    <tradeName>K-ASSAY Cystatin C Calibrator</tradeName>
    <deviceName>Cystatin C Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-099C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:58.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020757</udiDi>
    <basicUdiDi>B-00816426020757</basicUdiDi>
    <tradeName>K-ASSAY hsCRP Calibrator</tradeName>
    <deviceName>hsCRP Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-161C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:54.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020719</udiDi>
    <basicUdiDi>B-00816426020719</basicUdiDi>
    <tradeName>K-ASSAY Factor XIII Calibrator</tradeName>
    <deviceName>Factor XIII Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-106C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:54.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020689</udiDi>
    <basicUdiDi>B-00816426020689</basicUdiDi>
    <tradeName>K-ASSAY Ferritin Calibrator</tradeName>
    <deviceName>Ferritin Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-094C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:53.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020634</udiDi>
    <basicUdiDi>B-00816426020634</basicUdiDi>
    <tradeName>K-ASSAY CRP(3) Calibrator E</tradeName>
    <deviceName>CRP(3) Calibrator E</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-084C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:52.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020627</udiDi>
    <basicUdiDi>B-00816426020627</basicUdiDi>
    <tradeName>K-ASSAY ASO Calibrator</tradeName>
    <deviceName>ASO Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-079C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:47.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020610</udiDi>
    <basicUdiDi>B-00816426020610</basicUdiDi>
    <tradeName>K-ASSAY Serum/Plasma Alpha-1 Microglobulin Calibrator</tradeName>
    <deviceName>Serum/Plasma Alpha-1 Microglobulin Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-068C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:46.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020603</udiDi>
    <basicUdiDi>B-00816426020603</basicUdiDi>
    <tradeName>K-ASSAY Urine Alpha-1 Microglobulin Calibrator</tradeName>
    <deviceName>Urine Alpha-1 Microglobulin Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-067C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:46.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020580</udiDi>
    <basicUdiDi>B-00816426020580</basicUdiDi>
    <tradeName>K-ASSAY Apo AII/CII/CIII Calibrator</tradeName>
    <deviceName>Apo AII/CII/CIII Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-041C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:45.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020573</udiDi>
    <basicUdiDi>B-00816426020573</basicUdiDi>
    <tradeName>K-ASSAY Lp(a) Calibrator</tradeName>
    <deviceName>Lp(a) Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-018C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:41.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020566</udiDi>
    <basicUdiDi>B-00816426020566</basicUdiDi>
    <tradeName>K-ASSAY Multi-Analyte Calibrator</tradeName>
    <deviceName>Multi-Analyte Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-016C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:40.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020559</udiDi>
    <basicUdiDi>B-00816426020559</basicUdiDi>
    <tradeName>K-ASSAY CRP Calibrator</tradeName>
    <deviceName>CRP Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-012C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:39.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020498</udiDi>
    <basicUdiDi>B-00816426020498</basicUdiDi>
    <tradeName>K-ASSAY hsCRP</tradeName>
    <deviceName>hsCRP Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-160</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:38.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020467</udiDi>
    <basicUdiDi>B-00816426020467</basicUdiDi>
    <tradeName>K-ASSAY Factor XIII</tradeName>
    <deviceName>Factor XIII Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-105</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:34.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020450</udiDi>
    <basicUdiDi>B-00816426020450</basicUdiDi>
    <tradeName>K-ASSAY Ferritin</tradeName>
    <deviceName>Ferritin Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-095</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:33.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020443</udiDi>
    <basicUdiDi>B-00816426020443</basicUdiDi>
    <tradeName>K-ASSAY Microalbumin Calibrator</tradeName>
    <deviceName>Microalbumin Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-020C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:32.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020436</udiDi>
    <basicUdiDi>B-00816426020436</basicUdiDi>
    <tradeName>K-ASSAY Apo E Calibrator</tradeName>
    <deviceName>Apo E Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010499</emdnCode>
    <emdnDescription>LIPOPROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-025C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:31.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020412</udiDi>
    <basicUdiDi>B-00816426020412</basicUdiDi>
    <tradeName>K-ASSAY Insulin Calibrator</tradeName>
    <deviceName>Insulin Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-072C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:27.676Z</lastUpdated>
  </row>
</eudamedExport>