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<eudamedExport entity="devices">
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    <basicUdiDi>0405686901798WQ</basicUdiDi>
    <tradeName>Atellica IM Alpha Fetoprotein (AFP)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995441</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:38.467Z</lastUpdated>
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  <row>
    <udiDi>00630414597713</udiDi>
    <basicUdiDi>0405686901798WQ</basicUdiDi>
    <tradeName>Atellica IM Alpha Fetoprotein (AFP)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995442</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:38.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026117423</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR FIT Latex Reagent (for OC-SENSOR Micro)</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>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH33</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026165837</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR FIT Latex Reagent (for OC-SENSOR DIANA, 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026165844</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR FIT Buffer (for OC-SENSOR DIANA, 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026182308</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR FIT Latex Reagent (for OC-SENSOR io)</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>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026182322</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-FIT Calibrator (for OC-SENSOR DIANA, Micro)</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>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH51</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026182339</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-FIT Calibrator (for OC-SENSOR PLEDIA, io)</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>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH52</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026182346</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-FIT 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH53</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.113Z</lastUpdated>
  </row>
  <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>W0102039013</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>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>W0102039013</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>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>W0102039013</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>W0102039013</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>W0102039013</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>
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    <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>W0102039013</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>
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    <udiDi>04987295655558</udiDi>
    <basicUdiDi>4987295BU001ZR</basicUdiDi>
    <tradeName>EXTEL HEMO・AUTO Buffer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canon Medical Diagnostics Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000020364</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65555</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:22.957Z</lastUpdated>
  </row>
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    <udiDi>04987295655565</udiDi>
    <basicUdiDi>4987295BU001ZR</basicUdiDi>
    <tradeName>EXTEL HEMO・AUTO HS Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canon Medical Diagnostics Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000020364</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65556</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:22.936Z</lastUpdated>
  </row>
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    <udiDi>04987295655572</udiDi>
    <basicUdiDi>4987295BU001ZR</basicUdiDi>
    <tradeName>EXTEL HEMO・AUTO HS Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canon Medical Diagnostics Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000020364</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65557</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:22.913Z</lastUpdated>
  </row>
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    <udiDi>04987295660965</udiDi>
    <basicUdiDi>4987295BU001ZR</basicUdiDi>
    <tradeName>EXTEL HEMO・AUTO HS Liquid Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canon Medical Diagnostics Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000020364</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66096</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:22.842Z</lastUpdated>
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    <udiDi>04987295660972</udiDi>
    <basicUdiDi>4987295BU001ZR</basicUdiDi>
    <tradeName>EXTEL HEMO・AUTO NE Liquid Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Canon Medical Diagnostics Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000020364</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66097</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:22.820Z</lastUpdated>
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