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<eudamedExport entity="devices">
  <row>
    <udiDi>05051700006538</udiDi>
    <basicUdiDi>B-05051700006538</basicUdiDi>
    <tradeName>Human IgA 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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK088.1T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:56:45.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700007634</udiDi>
    <basicUdiDi>B-05051700007634</basicUdiDi>
    <tradeName>Human IgG1 Subclass 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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK006.TB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:56:45.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700007641</udiDi>
    <basicUdiDi>B-05051700007641</basicUdiDi>
    <tradeName>Human IgG2 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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK007.2TB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:56:45.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700007733</udiDi>
    <basicUdiDi>B-05051700007733</basicUdiDi>
    <tradeName>Human IgG2 Subclass 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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK007.TB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:56:45.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700007801</udiDi>
    <basicUdiDi>B-05051700007801</basicUdiDi>
    <tradeName>Human IgA1 Subclass 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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK087.1T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:56:45.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700011952</udiDi>
    <basicUdiDi>B-05051700011952</basicUdiDi>
    <tradeName>Human IgG2 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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK007.P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:56:45.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700021012</udiDi>
    <basicUdiDi>5051700LK022.OPT3J</basicUdiDi>
    <tradeName>Optilite® C2 Kit</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>COMPLEMENT COMPONENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK022.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:56:44.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700010603</udiDi>
    <basicUdiDi>B-05051700010603</basicUdiDi>
    <tradeName>Human Complement C5 NL BINDARID™ Kit</tradeName>
    <deviceName>Human Complement C5 NL BINDARID™ 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010299</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RN027.3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:13:09.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700010511</udiDi>
    <basicUdiDi>B-05051700010511</basicUdiDi>
    <tradeName>Human Complement C1q NL BINDARID™ Kit</tradeName>
    <deviceName>Human Complement C1q NL BINDARID™ 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010201</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C1Q</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RN020.3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:13:08.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700019347</udiDi>
    <basicUdiDi>5051700NK070.U.OPTPT</basicUdiDi>
    <tradeName>Optilite® Transferrin Urine Control Pack</tradeName>
    <deviceName>Optilite® Transferrin Urine 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>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ070.U.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:38:34.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700018340</udiDi>
    <basicUdiDi>5051700NK622.OPT86</basicUdiDi>
    <tradeName>Optilite® Hevylite® IgG Lambda Kit</tradeName>
    <deviceName>Optilite® Hevylite® IgG Lambda 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK622.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:38:33.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700018333</udiDi>
    <basicUdiDi>5051700NK621.OPT7T</basicUdiDi>
    <tradeName>Optilite® Hevylite® IgG Kappa Kit</tradeName>
    <deviceName>Optilite® Hevylite® IgG Kappa 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK621.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:38:32.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700018111</udiDi>
    <basicUdiDi>5051700NK626.OPT9J</basicUdiDi>
    <tradeName>Optilite® Hevylite® IgM Lambda Kit</tradeName>
    <deviceName>Optilite® Hevylite® IgM Lambda 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK626.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:38:32.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700018104</udiDi>
    <basicUdiDi>5051700NK625.OPT97</basicUdiDi>
    <tradeName>Optilite® Hevylite® IgM Kappa Kit</tradeName>
    <deviceName>Optilite® Hevylite® IgM Kappa 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK625.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:38:31.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700017824</udiDi>
    <basicUdiDi>5051700NK624.OPT8U</basicUdiDi>
    <tradeName>Optilite® Hevylite® IgA Lambda Kit</tradeName>
    <deviceName>Optilite® Hevylite® IgA Lambda 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK624.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:38:30.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700017817</udiDi>
    <basicUdiDi>5051700NK623.OPT8H</basicUdiDi>
    <tradeName>Optilite® Hevylite® IgA Kappa Kit</tradeName>
    <deviceName>Optilite® Hevylite® IgA Kappa 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK623.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:38:29.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700017367</udiDi>
    <basicUdiDi>5051700NK087.OPT95</basicUdiDi>
    <tradeName>Optilite® IgA1 Kit</tradeName>
    <deviceName>Optilite® IgA1 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 A SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK087.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:38:28.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700015554</udiDi>
    <basicUdiDi>5051700SN114.S9F</basicUdiDi>
    <tradeName>SPAPLUS® SAMPLE DILUENT 2 PACK</tradeName>
    <deviceName>SPAPLUS® SAMPLE DILUENT 2 PACK</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SN114.S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:38:27.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700011051</udiDi>
    <basicUdiDi>5051700SN080.S9Z</basicUdiDi>
    <tradeName>SPAPLUS® SAMPLE DILUENT PACK</tradeName>
    <deviceName>SPAPLUS® Sample Diluent Pack</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>SN080.S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:38:26.489Z</lastUpdated>
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  <row>
    <udiDi>05051700020909</udiDi>
    <basicUdiDi>5051700IK702GP</basicUdiDi>
    <tradeName>TENCELL™ Cuvettes</tradeName>
    <deviceName>TENCELL™ Cuvettes</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IK702</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:36:21.044Z</lastUpdated>
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</eudamedExport>