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<eudamedExport entity="devices">
  <row>
    <udiDi>04987026182353</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-FIT Control LV2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH54</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026190976</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 without barcode (VCPZ30)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026190983</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 without barcode (VCPZ31)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026205458</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 (VCPZ32)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026208381</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 (VCPZ34)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026210889</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-FIT Control LV3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH59</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026232478</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 (VCPZ36)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ25</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026239101</udiDi>
    <basicUdiDi>4987026TD-OCFCYC</basicUdiDi>
    <tradeName>OC-FCa Reagent (OC-SENSOR PLEDIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH11</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026239118</udiDi>
    <basicUdiDi>4987026TD-OCFCYC</basicUdiDi>
    <tradeName>OC-FCa Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026239125</udiDi>
    <basicUdiDi>4987026TD-OCFCYC</basicUdiDi>
    <tradeName>OC-FCa Control LV1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH13</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026239132</udiDi>
    <basicUdiDi>4987026TD-OCFCYC</basicUdiDi>
    <tradeName>OC-FCa Control LV2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH14</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026354248</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR Sample Diluent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026354958</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR FIT for OC-SENSOR Ceres</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026354965</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-FIT Calibrator for OC-SENSOR Ceres</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026354972</udiDi>
    <basicUdiDi>4987026TD-OCFCYC</basicUdiDi>
    <tradeName>OC-FCa Reagent (OC-SENSOR Ceres)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH09</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026354989</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR Sample Diluent (For OC-SENSOR Ceres)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026355214</udiDi>
    <basicUdiDi>4987026TD-OCEQZ5</basicUdiDi>
    <tradeName>OC-SENSOR Ceres</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MV5K00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:23.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145206705</udiDi>
    <basicUdiDi>4987026TD-LFMPZM</basicUdiDi>
    <tradeName>Loopamp™ Malaria Pan Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-13T09:57:54.888Z</lastUpdated>
  </row>
</eudamedExport>