<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00816784020802</udiDi>
    <basicUdiDi>B-00816784020802</basicUdiDi>
    <tradeName>ACCURUN 315 HIV-1 RNA Positive Quality Control Series 500</tradeName>
    <deviceName>ACCURUN 315 HIV-1 RNA Positive Quality Control Series 500</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0093</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:43.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020574</udiDi>
    <basicUdiDi>B-00816784020574</basicUdiDi>
    <tradeName>ACCURUN 315 Series 400 HIV-1 RNA</tradeName>
    <deviceName>ACCURUN 315 Series 400 HIV-1 RNA</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0092</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:56.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020567</udiDi>
    <basicUdiDi>B-00816784020567</basicUdiDi>
    <tradeName>ACCURUN 315 Series 200 HIV-1 RNA</tradeName>
    <deviceName>ACCURUN 315 Series 200 HIV-1 RNA</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0090</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:55.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020550</udiDi>
    <basicUdiDi>B-00816784020550</basicUdiDi>
    <tradeName>ACCURUN 315 Series 150 HIV-1 RNA</tradeName>
    <deviceName>ACCURUN 315 Series 150 HIV-1 RNA</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0087</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:55.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020260</udiDi>
    <basicUdiDi>B-00816784020260</basicUdiDi>
    <tradeName>A106 HIV-1 Ag</tradeName>
    <deviceName>A106 HIV-1 Ag</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0066</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:56.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020253</udiDi>
    <basicUdiDi>B-00816784020253</basicUdiDi>
    <tradeName>A106 HIV-1 Ag</tradeName>
    <deviceName>A106 HIV-1 Ag</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0065</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:54.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670545</udiDi>
    <basicUdiDi>426046567SRHIV2HT</basicUdiDi>
    <tradeName>Optitrol HIV 2</tradeName>
    <deviceName>Optitrol HIV 2</deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:41:06.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670507</udiDi>
    <basicUdiDi>426046567SRHIVp24DE</basicUdiDi>
    <tradeName>Optitrol HIVp24</tradeName>
    <deviceName>Optitrol HIVp24</deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:41:04.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670514</udiDi>
    <basicUdiDi>426046567SRHIVp24DE</basicUdiDi>
    <tradeName>Optitrol HIVp24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670521</udiDi>
    <basicUdiDi>426046567SRHIVp24DE</basicUdiDi>
    <tradeName>Optitrol HIVp24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670538</udiDi>
    <basicUdiDi>426046567SRHIVp24DE</basicUdiDi>
    <tradeName>Optitrol HIVp24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11107</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670552</udiDi>
    <basicUdiDi>426046567SRHIV2HT</basicUdiDi>
    <tradeName>Optitrol HIV 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11115</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670569</udiDi>
    <basicUdiDi>426046567SRHIV2HT</basicUdiDi>
    <tradeName>Optitrol HIV 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11117</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.483Z</lastUpdated>
  </row>
</eudamedExport>