<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850011135006</udiDi>
    <basicUdiDi>B-00850011135006</basicUdiDi>
    <tradeName>VALIDATE® UC1 Test Set</tradeName>
    <deviceName>VALIDATE® UC1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701ri</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:56:04.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784021007</udiDi>
    <basicUdiDi>B-00816784021007</basicUdiDi>
    <tradeName>A1 Negative Control</tradeName>
    <deviceName>A1 Negative 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>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-0013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:53.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020970</udiDi>
    <basicUdiDi>B-00816784020970</basicUdiDi>
    <tradeName>ACCURUN Anti-SARS-CoV-2 Series 2000</tradeName>
    <deviceName>ACCURUN Anti-SARS-CoV-2 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>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0225</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:51.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020963</udiDi>
    <basicUdiDi>B-00816784020963</basicUdiDi>
    <tradeName>ACCURUN Anti-SARS-CoV-2 Series 1000</tradeName>
    <deviceName>ACCURUN Anti-SARS-CoV-2 Series 1000</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>2015-0222</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:49.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020956</udiDi>
    <basicUdiDi>B-00816784020956</basicUdiDi>
    <tradeName>ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000</tradeName>
    <deviceName>ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000</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>2000-0062</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:48.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020949</udiDi>
    <basicUdiDi>B-00816784020949</basicUdiDi>
    <tradeName>ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000</tradeName>
    <deviceName>ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000</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>2000-0067</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:47.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020871</udiDi>
    <basicUdiDi>B-00816784020871</basicUdiDi>
    <tradeName>A1 Series 2700</tradeName>
    <deviceName>A1 Series 2700</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>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:44.880Z</lastUpdated>
  </row>
  <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>00816784020796</udiDi>
    <basicUdiDi>B-00816784020796</basicUdiDi>
    <tradeName>Accurun 2 Series 2700</tradeName>
    <deviceName>Accurun 2 Series 2700</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>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0024</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:42.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020819</udiDi>
    <basicUdiDi>B-00816784020819</basicUdiDi>
    <tradeName>ACCURUN 872 HPV DNA Negative Control</tradeName>
    <deviceName>ACCURUN 872 HPV DNA Negative 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>2035-0009</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:40.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020789</udiDi>
    <basicUdiDi>B-00816784020789</basicUdiDi>
    <tradeName>Accurun 1 S8100 Positive Control</tradeName>
    <deviceName>Accurun 1 S8100 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>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0022</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:38.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020772</udiDi>
    <basicUdiDi>B-00816784020772</basicUdiDi>
    <tradeName>Accurun 1 Series 5100 Positive Control</tradeName>
    <deviceName>Accurun 1 Series 5100 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>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0017</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:23.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020765</udiDi>
    <basicUdiDi>B-00816784020765</basicUdiDi>
    <tradeName>Accurun 1 Series 5100 positive control</tradeName>
    <deviceName>Accurun 1 Series 5100 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>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0016</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:22.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020758</udiDi>
    <basicUdiDi>B-00816784020758</basicUdiDi>
    <tradeName>ACCURUN 501 C. difficile Control</tradeName>
    <deviceName>ACCURUN 501 C. difficile 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>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2050-0008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:21.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020727</udiDi>
    <basicUdiDi>B-00816784020727</basicUdiDi>
    <tradeName>ACCURUN 25 ToRCH IgG Positive Control S2000</tradeName>
    <deviceName>ACCURUN 25 ToRCH IgG Positive Control S2000</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>2000-0074</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:20.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020710</udiDi>
    <basicUdiDi>B-00816784020710</basicUdiDi>
    <tradeName>ACCURUN 803 Nucleic Acid Negative Quality Control</tradeName>
    <deviceName>ACCURUN 803 Nucleic Acid Negative Quality 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>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2035-0007</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:16.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020703</udiDi>
    <basicUdiDi>B-00816784020703</basicUdiDi>
    <tradeName>ACCURUN 873 HPV DNA Negative Control</tradeName>
    <deviceName>ACCURUN 873 HPV DNA Negative 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>2035-0005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:16.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020697</udiDi>
    <basicUdiDi>B-00816784020697</basicUdiDi>
    <tradeName>ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700</tradeName>
    <deviceName>ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700</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>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2025-0068</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:15.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020680</udiDi>
    <basicUdiDi>B-00816784020680</basicUdiDi>
    <tradeName>ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100</tradeName>
    <deviceName>ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100</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>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2025-0067</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:14.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020673</udiDi>
    <basicUdiDi>B-00816784020673</basicUdiDi>
    <tradeName>ACCURUN 841 CT/NG Negative Control</tradeName>
    <deviceName>ACCURUN 841 CT/NG Negative 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>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2025-0061</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:42:10.391Z</lastUpdated>
  </row>
</eudamedExport>