<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-7465934594DH</udiDi>
    <basicUdiDi>B-7465934594DH</basicUdiDi>
    <tradeName>OI-immune profiling assay</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OI-IPA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:52.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-820133-1652G</udiDi>
    <basicUdiDi>B-820133-1652G</basicUdiDi>
    <tradeName>D-820133-1652G</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>820133-165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:17.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Anti-AAV6nAbAssayLM</udiDi>
    <basicUdiDi>B-Anti-AAV6nAbAssayLM</basicUdiDi>
    <tradeName>Anti-AAV6 nAb Assay</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-AAV6 nAb Assay</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Anti-AAV9nAbAssayNS</udiDi>
    <basicUdiDi>B-Anti-AAV9nAbAssayNS</basicUdiDi>
    <tradeName>Anti-AAv9 nAb</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-AAV9 nAb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AntiSpark100nAbAssay8B</udiDi>
    <basicUdiDi>B-AntiSpark100nAbAssay8B</basicUdiDi>
    <tradeName>nAbCyte Anti-AAVRh74var HB-FE Assay</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-Spark 100 nAb Assay</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-APOL1_80-061-00TX</udiDi>
    <basicUdiDi>B-APOL1_80-061-00TX</basicUdiDi>
    <tradeName>D-APOL1_80-061-00TX</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-061-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:32:57.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TSO500LDTJF</udiDi>
    <basicUdiDi>B-TSO500LDTJF</basicUdiDi>
    <tradeName>D-TSO500LDTJF</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSO500LDT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:11.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-US-MF-000017722U2</udiDi>
    <basicUdiDi>B-US-MF-000017722U2</basicUdiDi>
    <tradeName>OI-genomic profiling assay</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OI-GPA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:02.190Z</lastUpdated>
  </row>
</eudamedExport>