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<eudamedExport entity="devices">
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    <udiDi>15099590010966</udiDi>
    <basicUdiDi>150995901OSR61105SJ</basicUdiDi>
    <tradeName>RF Latex</tradeName>
    <deviceName>RF Latex</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010199</emdnCode>
    <emdnDescription>IMMUNOGLOBULINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR61105</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:29:16.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AntiSpark100nAbAssay8B</udiDi>
    <basicUdiDi>B-AntiSpark100nAbAssay8B</basicUdiDi>
    <tradeName>nAbCyte Anti-AAVRh74var HB-FE Assay</tradeName>
    <deviceName>nAbCyte Anti-AAVRh74var HB-FE Assay</deviceName>
    <manufacturerName>Laboratory Corporation of America Holdings</manufacturerName>
    <manufacturerSrn>US-MF-000017722</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010199</emdnCode>
    <emdnDescription>IMMUNOGLOBULINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-Spark 100 nAb Assay</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:46:28.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Anti-AAV9nAbAssayNS</udiDi>
    <basicUdiDi>B-Anti-AAV9nAbAssayNS</basicUdiDi>
    <tradeName>Anti-AAv9 nAb</tradeName>
    <deviceName>Anti-AAV9 nAb Assay</deviceName>
    <manufacturerName>Laboratory Corporation of America Holdings</manufacturerName>
    <manufacturerSrn>US-MF-000017722</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010199</emdnCode>
    <emdnDescription>IMMUNOGLOBULINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-AAV9 nAb</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:46:25.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Anti-AAV6nAbAssayLM</udiDi>
    <basicUdiDi>B-Anti-AAV6nAbAssayLM</basicUdiDi>
    <tradeName>Anti-AAV6 nAb Assay</tradeName>
    <deviceName>Anti-AAV6 nAb Assay</deviceName>
    <manufacturerName>Laboratory Corporation of America Holdings</manufacturerName>
    <manufacturerSrn>US-MF-000017722</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010199</emdnCode>
    <emdnDescription>IMMUNOGLOBULINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-AAV6 nAb Assay</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:46:20.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753472927</udiDi>
    <basicUdiDi>B-06976753472927</basicUdiDi>
    <tradeName>IgE Rapid Test Device (whole blood/serum/plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010199</emdnCode>
    <emdnDescription>IMMUNOGLOBULINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D020501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:17.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565455</udiDi>
    <basicUdiDi>B-06974541565455</basicUdiDi>
    <tradeName>06974541565455</tradeName>
    <deviceName>Luteinising Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010199</emdnCode>
    <emdnDescription>IMMUNOGLOBULINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2230</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:23.749Z</lastUpdated>
  </row>
</eudamedExport>