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    <basicUdiDi>0405686901807VY</basicUdiDi>
    <tradeName>ADVIA Centaur Cyclosporine</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_CsA</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>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10335448</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:01.725Z</lastUpdated>
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    <udiDi>00842768025136</udiDi>
    <basicUdiDi>0405686901242V4</basicUdiDi>
    <tradeName>Dimension Cyclosporine A Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_CSA</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>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10285193</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:27.754Z</lastUpdated>
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  <row>
    <udiDi>00842768001451</udiDi>
    <basicUdiDi>0405686901249VJ</basicUdiDi>
    <tradeName>Emit 2000 Cyclosporine Specific Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Cyclosporine Specific 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>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445375</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:05.998Z</lastUpdated>
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  <row>
    <udiDi>D-VID126EX</udiDi>
    <basicUdiDi>B-VID126EX</basicUdiDi>
    <tradeName>VivaDiag Cyclosporin A Test Kit (FIA)</tradeName>
    <deviceName>VivaDiag Cyclosporin A Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID126-13-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:19.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590506</udiDi>
    <basicUdiDi>697518250F114092E</basicUdiDi>
    <tradeName>Cyclosporine A CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cyclosporine A CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11409</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:29:16.117Z</lastUpdated>
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  <row>
    <udiDi>06942293581115</udiDi>
    <basicUdiDi>697518250P114096G</basicUdiDi>
    <tradeName>Cyclosporine A Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Cyclosporine A Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080602</emdnCode>
    <emdnDescription>CYCLOSPORINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11409</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:47.416Z</lastUpdated>
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