<?xml version="1.0" encoding="UTF-8"?>
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    <udiDi>04987481163829</udiDi>
    <basicUdiDi>498748114987481163802ZB</basicUdiDi>
    <tradeName>LAL Control</tradeName>
    <deviceName>β-Glucan Test R1: Pretreatment Solution, β-Glucan Test R2: LAL Reagent, LAL Control</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080806</emdnCode>
    <emdnDescription>MYCOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>995-04401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:41.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436610290142</udiDi>
    <basicUdiDi>843661029VEC00101GM</basicUdiDi>
    <tradeName>VIRCELL® ASPERGILLUS GALACTOMANNAN AG CONTROL</tradeName>
    <deviceName>VIRCELL® ASPERGILLUS GALACTOMANNAN AG CONTROL</deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080806</emdnCode>
    <emdnDescription>MYCOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VEC001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:57:44.604Z</lastUpdated>
  </row>
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