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    <basicUdiDi>0405686901308V9</basicUdiDi>
    <tradeName>Emit 2000 Sirolimus Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Sirolimus Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080604</emdnCode>
    <emdnDescription>RAPAMYCIN (SIROLIMUS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:47.214Z</lastUpdated>
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    <udiDi>00842768022111</udiDi>
    <basicUdiDi>0405686901305V3</basicUdiDi>
    <tradeName>Dimension Sirolimus Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_SIRO</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080604</emdnCode>
    <emdnDescription>RAPAMYCIN (SIROLIMUS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10464331</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:06.612Z</lastUpdated>
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  <row>
    <udiDi>D-4180PIMMNG</udiDi>
    <basicUdiDi>B-4180PIMMNG</basicUdiDi>
    <tradeName>Immunosuppressants Reagent Set</tradeName>
    <deviceName>Immunosuppressants 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>W0102080604</emdnCode>
    <emdnDescription>RAPAMYCIN (SIROLIMUS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4180 P IMM</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:28.953Z</lastUpdated>
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    <udiDi>06942293591619</udiDi>
    <basicUdiDi>697518250F1142124</basicUdiDi>
    <tradeName>Rapamycin CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Rapamycin CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080604</emdnCode>
    <emdnDescription>RAPAMYCIN (SIROLIMUS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11421</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:37.812Z</lastUpdated>
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