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    <basicUdiDi>B-08426950594864</basicUdiDi>
    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® aPS PT IgG ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708835</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:20:13.942Z</lastUpdated>
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    <udiDi>08426950594796</udiDi>
    <basicUdiDi>B-08426950594796</basicUdiDi>
    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® aPS PT IgM ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>708845</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:20:13.135Z</lastUpdated>
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    <udiDi>06975424226623</udiDi>
    <basicUdiDi>B-06975424226623</basicUdiDi>
    <tradeName>Anti-aPS/PT IgM CLIA Assay Kit</tradeName>
    <deviceName>Anti-aPS/PT IgM CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20292EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:46:46.024Z</lastUpdated>
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    <udiDi>06975424226593</udiDi>
    <basicUdiDi>B-06975424226593</basicUdiDi>
    <tradeName>Anti-aPS/PT IgG  CLIA Assay Kit</tradeName>
    <deviceName>Anti-aPS/PT IgG  CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20302EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:46:41.210Z</lastUpdated>
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    <udiDi>06975424224094</udiDi>
    <basicUdiDi>B-06975424224094</basicUdiDi>
    <tradeName>Anti-aPS/PT IgM CLIA Assay Kit</tradeName>
    <deviceName>Anti-aPS/PT IgM CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30292EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:09.882Z</lastUpdated>
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  <row>
    <udiDi>06975424224063</udiDi>
    <basicUdiDi>B-06975424224063</basicUdiDi>
    <tradeName>Anti-aPS/PT IgG  CLIA Assay Kit</tradeName>
    <deviceName>Anti-aPS/PT IgG  CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30302EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:04.277Z</lastUpdated>
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  <row>
    <udiDi>06975424222373</udiDi>
    <basicUdiDi>B-06975424222373</basicUdiDi>
    <tradeName>Anti-aPS/PT IgM CLIA Assay Kit</tradeName>
    <deviceName>Anti-aPS/PT IgM CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:38:15.170Z</lastUpdated>
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    <udiDi>06975424222366</udiDi>
    <basicUdiDi>B-06975424222366</basicUdiDi>
    <tradeName>Anti-aPS/PT IgG  CLIA Assay Kit</tradeName>
    <deviceName>Anti-aPS/PT IgG  CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:38:11.145Z</lastUpdated>
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  <row>
    <udiDi>06975070762377</udiDi>
    <basicUdiDi>B-06975070762377</basicUdiDi>
    <tradeName>Sharay APS IgM (CLIA)</tradeName>
    <deviceName>Sharay APS IgM (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18157001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:38:03.471Z</lastUpdated>
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  <row>
    <udiDi>06975070762360</udiDi>
    <basicUdiDi>B-06975070762360</basicUdiDi>
    <tradeName>Sharay APS IgG (CLIA)</tradeName>
    <deviceName>Sharay APS IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18516001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:38:01.861Z</lastUpdated>
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  <row>
    <udiDi>06975424222854</udiDi>
    <basicUdiDi>B-06975424222854</basicUdiDi>
    <tradeName>Anti-aPS/PT IgM CLIA Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30292E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:32:58.748Z</lastUpdated>
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    <udiDi>06975424222847</udiDi>
    <basicUdiDi>B-06975424222847</basicUdiDi>
    <tradeName>Anti-aPS/PT IgG  CLIA Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30302E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:32:56.273Z</lastUpdated>
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