<?xml version="1.0" encoding="UTF-8"?>
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    <udiDi>00630414598680</udiDi>
    <basicUdiDi>0405686901806VW</basicUdiDi>
    <tradeName>Atellica IM Complexed Prostate-Specific Antigen (cPSA)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_cPSA</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>W0102030115</emdnCode>
    <emdnDescription>COMPLEXED PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995544</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:09.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414450896</udiDi>
    <basicUdiDi>0405686901806VW</basicUdiDi>
    <tradeName>ADVIA Centaur® cPSA</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_cPSA</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>W0102030115</emdnCode>
    <emdnDescription>COMPLEXED PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10310381</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:54.901Z</lastUpdated>
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</eudamedExport>