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    <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>W0102010102</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK087.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:05:04.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700017244</udiDi>
    <basicUdiDi>5051700LK088.OPT82</basicUdiDi>
    <tradeName>Optilite® IgA2 Kit</tradeName>
    <deviceName>Optilite® IgA2 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>W0102010102</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK088.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:04:59.239Z</lastUpdated>
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  <row>
    <udiDi>05051700007801</udiDi>
    <basicUdiDi>B-05051700007801</basicUdiDi>
    <tradeName>Human IgA1 Subclass Kit (for Siemens BN™II)</tradeName>
    <deviceName>Human IgA1 Subclass Kit (for Siemens BN™II)</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>W0102010102</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK087.1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:50.395Z</lastUpdated>
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    <udiDi>05051700006538</udiDi>
    <basicUdiDi>B-05051700006538</basicUdiDi>
    <tradeName>Human IgA Subclass Latex Kit (for Siemens BN™II)</tradeName>
    <deviceName>Human IgA Subclass Latex Kit (for Siemens BN™II)</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>W0102010102</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK088.1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:34.281Z</lastUpdated>
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    <udiDi>08707696700017</udiDi>
    <basicUdiDi>87076967AuramineV4C3</basicUdiDi>
    <tradeName>08707696700017</tradeName>
    <deviceName>Diagnostic Consumable Kit Auramine V4</deviceName>
    <manufacturerName>Svizera Europe BV</manufacturerName>
    <manufacturerSrn>NL-MF-000047495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010102</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Auramine V4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:16:47.721Z</lastUpdated>
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  <row>
    <udiDi>05051700019262</udiDi>
    <basicUdiDi>5051700LK088.OPT82</basicUdiDi>
    <tradeName>Optilite® IgA2 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>W0102010102</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ088.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:16.057Z</lastUpdated>
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    <udiDi>05051700019330</udiDi>
    <basicUdiDi>5051700NK087.OPT95</basicUdiDi>
    <tradeName>Optilite® IgA1 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>W0102010102</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ087.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:15.999Z</lastUpdated>
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