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<eudamedExport entity="devices">
  <row>
    <udiDi>00816784020604</udiDi>
    <basicUdiDi>B-00816784020604</basicUdiDi>
    <tradeName>A325 Series 700 HBV DNA</tradeName>
    <deviceName>A325 Series 700 HBV DNA</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>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0098</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:01.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020598</udiDi>
    <basicUdiDi>B-00816784020598</basicUdiDi>
    <tradeName>A325 Series 200 HBV DNA</tradeName>
    <deviceName>A325 Series 200 HBV DNA</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>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0096</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:57.595Z</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>00816784020536</udiDi>
    <basicUdiDi>B-00816784020536</basicUdiDi>
    <tradeName>ACCURUN 305 Series 400 HCV RNA</tradeName>
    <deviceName>ACCURUN 305 Series 400 HCV 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>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0085</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:51.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020529</udiDi>
    <basicUdiDi>B-00816784020529</basicUdiDi>
    <tradeName>ACCURUN 305 Series 300 HCV RNA</tradeName>
    <deviceName>ACCURUN 305 Series 300 HCV 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>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0083</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:50.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020512</udiDi>
    <basicUdiDi>B-00816784020512</basicUdiDi>
    <tradeName>ACCURUN 305 Series 100 HCV RNA</tradeName>
    <deviceName>ACCURUN 305 Series 100 HCV 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>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0080</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:49.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020505</udiDi>
    <basicUdiDi>B-00816784020505</basicUdiDi>
    <tradeName>ACCURUN 305 Series 150 HCV RNA Positive Control</tradeName>
    <deviceName>ACCURUN 305 Series 150 HCV RNA Positive Control</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>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0078</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:48.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020499</udiDi>
    <basicUdiDi>B-00816784020499</basicUdiDi>
    <tradeName>ACCURUN 190 Chagas Positive Control</tradeName>
    <deviceName>ACCURUN 190 Chagas Positive Control</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>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0097</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:44.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020482</udiDi>
    <basicUdiDi>B-00816784020482</basicUdiDi>
    <tradeName>ACCURUN 156 Reagin (Syphilis) Positive Control</tradeName>
    <deviceName>ACCURUN 156 Reagin (Syphilis) Positive Control</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>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0094</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:43.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020475</udiDi>
    <basicUdiDi>B-00816784020475</basicUdiDi>
    <tradeName>ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000</tradeName>
    <deviceName>ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000</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>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0093</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:43.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020468</udiDi>
    <basicUdiDi>B-00816784020468</basicUdiDi>
    <tradeName>ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000</tradeName>
    <deviceName>ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000</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>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0092</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:42.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020437</udiDi>
    <basicUdiDi>B-00816784020437</basicUdiDi>
    <tradeName>ACCURUN 145 CMV IgG Positive Control</tradeName>
    <deviceName>ACCURUN 145 CMV IgG Positive Control</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0087</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:38.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020451</udiDi>
    <basicUdiDi>B-00816784020451</basicUdiDi>
    <tradeName>ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 2000</tradeName>
    <deviceName>ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 2000</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>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0090</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:37.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020444</udiDi>
    <basicUdiDi>B-00816784020444</basicUdiDi>
    <tradeName>ACCURUN 146 CMV IgM Positive Control</tradeName>
    <deviceName>ACCURUN 146 CMV IgM Positive Control</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0088</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:36.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020420</udiDi>
    <basicUdiDi>B-00816784020420</basicUdiDi>
    <tradeName>ACCURUN 141 Rubella IgM Positive Control</tradeName>
    <deviceName>ACCURUN 141 Rubella IgM Positive Control</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0086</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:21.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020413</udiDi>
    <basicUdiDi>B-00816784020413</basicUdiDi>
    <tradeName>ACCURUN 140 Rubella IgG Positive Control</tradeName>
    <deviceName>ACCURUN 140 Rubella IgG Positive Control</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0084</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:19.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020406</udiDi>
    <basicUdiDi>B-00816784020406</basicUdiDi>
    <tradeName>ACCURUN 136 Toxoplasma IgM Positive Control</tradeName>
    <deviceName>ACCURUN 136 Toxoplasma IgM Positive Control</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0083</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:19.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020390</udiDi>
    <basicUdiDi>B-00816784020390</basicUdiDi>
    <tradeName>ACCURUN 135 Toxoplasma IgG Positive Control</tradeName>
    <deviceName>ACCURUN 135 Toxoplasma IgG Positive Control</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0082</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:17.487Z</lastUpdated>
  </row>
</eudamedExport>