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<eudamedExport entity="devices">
  <row>
    <udiDi>05051700017015</udiDi>
    <basicUdiDi>5051700NK004.OPT4U</basicUdiDi>
    <tradeName>Optilite® IgG Kit</tradeName>
    <deviceName>Optilite® IgG Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK004.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:35:34.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700012102</udiDi>
    <basicUdiDi>5051700LK018.CBXT</basicUdiDi>
    <tradeName>Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems</tradeName>
    <deviceName>Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK018.CB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:35:32.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700012096</udiDi>
    <basicUdiDi>5051700LK016.CBXD</basicUdiDi>
    <tradeName>Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems</tradeName>
    <deviceName>Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK016.CB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:35:32.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700006071</udiDi>
    <basicUdiDi>B-05051700006071</basicUdiDi>
    <tradeName>Human IgG Subclass Combi Kit (for Siemens BN ProSpec®)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK001.P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700006095</udiDi>
    <basicUdiDi>B-05051700006095</basicUdiDi>
    <tradeName>Human IgA Subclass Combi Kit - Latex IgA2 (for Siemens BN™II)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK003.T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700006101</udiDi>
    <basicUdiDi>B-05051700006101</basicUdiDi>
    <tradeName>Human IgG3 Subclass (Latex) Bulk Kit (for Siemens BN™II)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK008.2TB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700006163</udiDi>
    <basicUdiDi>B-05051700006163</basicUdiDi>
    <tradeName>Human IgG3 Subclass Latex Kit (for Siemens BN™II)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK008.TB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700006170</udiDi>
    <basicUdiDi>B-05051700006170</basicUdiDi>
    <tradeName>Human IgG4 Subclass (Latex) Bulk Kit (for Siemens BN™II)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK009.2TB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700006248</udiDi>
    <basicUdiDi>B-05051700006248</basicUdiDi>
    <tradeName>Human IgG4 Subclass Latex Kit (for Siemens BN™II)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK009.TB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700006255</udiDi>
    <basicUdiDi>B-05051700006255</basicUdiDi>
    <tradeName>Human IgD Kit (for Siemens BN™II)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK013.T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700006378</udiDi>
    <basicUdiDi>B-05051700006378</basicUdiDi>
    <tradeName>Freelite® Human Kappa Free Kit (for use on the Siemens BN™II)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK016.T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700006491</udiDi>
    <basicUdiDi>B-05051700006491</basicUdiDi>
    <tradeName>Freelite® Human Lambda Free Kit (for use on the Siemens BN™II)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK018.T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700007559</udiDi>
    <basicUdiDi>B-05051700007559</basicUdiDi>
    <tradeName>Human IgG1 Subclass Bulk Kit (for Siemens BN™II)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK006.2TB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700011594</udiDi>
    <basicUdiDi>B-05051700011594</basicUdiDi>
    <tradeName>Human IgG3 Subclass Kit - (for use on the Siemens BN ProSpec®)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK008.P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700011600</udiDi>
    <basicUdiDi>B-05051700011600</basicUdiDi>
    <tradeName>Human IgG4 Subclass Kit - (for use on the Siemens BN ProSpec®)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK009.P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700011945</udiDi>
    <basicUdiDi>B-05051700011945</basicUdiDi>
    <tradeName>Human IgG1 Subclass Kit - (for use on the Siemens BN ProSpec®)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK006.P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:17.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700018562</udiDi>
    <basicUdiDi>5051700LK009.OPT55</basicUdiDi>
    <tradeName>Optilite® IgG4 Control Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ009.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:16.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700018579</udiDi>
    <basicUdiDi>5051700LK008.OPT4S</basicUdiDi>
    <tradeName>Optilite® IgG3 Control Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ008.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:16.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700018753</udiDi>
    <basicUdiDi>5051700LK018.OPT57</basicUdiDi>
    <tradeName>Optilite® Freelite® Lambda Free Control Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ018.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:16.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700018760</udiDi>
    <basicUdiDi>5051700LK016.OPT4H</basicUdiDi>
    <tradeName>Optilite® Freelite® Kappa Free Control Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ016.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:16.487Z</lastUpdated>
  </row>
</eudamedExport>