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    <basicUdiDi>0711234540124NB</basicUdiDi>
    <tradeName>GEM Hemochron 100</tradeName>
    <deviceName>GEM® Hemochron™ 100 System Centralized Configuration Manager</deviceName>
    <manufacturerName>Accriva Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009902</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020182</emdnCode>
    <emdnDescription>COAGULOMETERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000GCCM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:53:24.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>10711234540039</udiDi>
    <basicUdiDi>0711234540032N5</basicUdiDi>
    <tradeName>Hemochron™</tradeName>
    <deviceName>Hemochron™ Report Maker</deviceName>
    <manufacturerName>Accriva Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009902</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020182</emdnCode>
    <emdnDescription>COAGULOMETERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPM-CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:53:23.842Z</lastUpdated>
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