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    <udiDi>05414470815463</udiDi>
    <basicUdiDi>54144700375H</basicUdiDi>
    <tradeName>Lumipulse pTau 217 Plasma Controls &lt;2x2C, CE&gt;</tradeName>
    <deviceName>Lumipulse pTau 217 Plasma Controls</deviceName>
    <manufacturerName>Fujirebio Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001792</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81546</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:53:01.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>05414470815449</udiDi>
    <basicUdiDi>541447003155</basicUdiDi>
    <tradeName>Lumipulse G pTau 217 Plasma Immunoreaction Cartridges &lt;3x14T, CE&gt;</tradeName>
    <deviceName>Lumipulse G pTau 217 Plasma Immunoreaction Cartridges</deviceName>
    <manufacturerName>Fujirebio Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001792</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019017</emdnCode>
    <emdnDescription>PHOSPHORYLATED TAU (PTAU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81544</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:53:00.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>05414470815456</udiDi>
    <basicUdiDi>541447003155</basicUdiDi>
    <tradeName>Lumipulse G pTau 217 Plasma Calibrators &lt;1x5C, CE&gt;</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fujirebio Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001792</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019017</emdnCode>
    <emdnDescription>PHOSPHORYLATED TAU (PTAU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81545</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T05:52:22.170Z</lastUpdated>
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