<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05032384501854</udiDi>
    <basicUdiDi>5032384IdeiaLymeUV</basicUdiDi>
    <tradeName>IDEIA LYME NEUROBORRELIOSIS KIT</tradeName>
    <deviceName>IDEIA LYME NEUROBORRELIOSIS KIT</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010699</emdnCode>
    <emdnDescription>LYME BORRELIOSIS REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K602811-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:07.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771103732</udiDi>
    <basicUdiDi>80567713110303E</basicUdiDi>
    <tradeName>LIAISON® LymeDetect®</tradeName>
    <deviceName>LIAISON® LymeDetect®</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010699</emdnCode>
    <emdnDescription>LYME BORRELIOSIS REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311030</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:08:01.307Z</lastUpdated>
  </row>
</eudamedExport>