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<eudamedExport entity="devices">
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    <udiDi>05060169695986</udiDi>
    <basicUdiDi>5060169695986ZF</basicUdiDi>
    <tradeName>IDS Beta CrossLaps® (CTX-I)</tradeName>
    <deviceName>IDS  Beta CrossLaps® (CTX-I)</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-3000N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:33:02.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169690134</udiDi>
    <basicUdiDi>5060169690134WH</basicUdiDi>
    <tradeName>Serum CrossLaps® (CTX-I) ELISA</tradeName>
    <deviceName>Serum CrossLaps® (CTX-I) ELISA</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-02F1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:30.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169690158</udiDi>
    <basicUdiDi>5060169690158WX</basicUdiDi>
    <tradeName>Urine BETA CrossLaps® (CTX-I) ELISA</tradeName>
    <deviceName>Urine BETA CrossLaps® (CTX-I) ELISA</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-05F1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:29.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169690141</udiDi>
    <basicUdiDi>5060169690141WE</basicUdiDi>
    <tradeName>Urine CrossLaps® (CTX-I) EIA</tradeName>
    <deviceName>Urine CrossLaps® (CTX-I) EIA</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-03F1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:28.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK016DM</udiDi>
    <basicUdiDi>B-SEK016DM</basicUdiDi>
    <tradeName>β-cTx Assay Kit (ECLIA)</tradeName>
    <deviceName>β-cTx Assay Kit (ECLIA)</deviceName>
    <manufacturerName>Jiangsu Sunlant Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025940</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:50.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075845</udiDi>
    <basicUdiDi>B-06978139075845</basicUdiDi>
    <tradeName>LH Test (FIA)</tradeName>
    <deviceName>LH Test (FIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320302702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:13.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139071304</udiDi>
    <basicUdiDi>B-06978139071304</basicUdiDi>
    <tradeName>LH Test (FIA)</tradeName>
    <deviceName>LH Test (FIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060304</emdnCode>
    <emdnDescription>CROSS-LINKED C-TELOPEPTIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320302702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:01.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169696013</udiDi>
    <basicUdiDi>5060169695986ZF</basicUdiDi>
    <tradeName>IDS Beta CrossLaps® (CTX-I) Calibrator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060304</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-3020N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:44:55.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169696051</udiDi>
    <basicUdiDi>5060169695986ZF</basicUdiDi>
    <tradeName>IDS Beta CrossLaps® (CTX-I) Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060304</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-3030N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:44:55.672Z</lastUpdated>
  </row>
</eudamedExport>