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<eudamedExport entity="devices">
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    <udiDi>00884883008991</udiDi>
    <basicUdiDi>0884883QCDDFRREC15580D4</basicUdiDi>
    <tradeName>00884883008991</tradeName>
    <deviceName>QMS Omecamtiv Mecarbil Immunoassay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080199</emdnCode>
    <emdnDescription>CARDIOVASCULAR TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10023163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:23:44.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4160PCARKW</udiDi>
    <basicUdiDi>B-4160PCARKW</basicUdiDi>
    <tradeName>Cardiac Medication Reagent Set</tradeName>
    <deviceName>Cardiac Medication Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080199</emdnCode>
    <emdnDescription>CARDIOVASCULAR TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4160 P CAR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:21.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-20000E4</udiDi>
    <basicUdiDi>B-20000E4</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Amiodarone in Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080199</emdnCode>
    <emdnDescription>CARDIOVASCULAR TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:16.281Z</lastUpdated>
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