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<eudamedExport entity="devices">
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    <udiDi>00816784020352</udiDi>
    <basicUdiDi>B-00816784020352</basicUdiDi>
    <tradeName>ACCURUN 125 Anti-HBs Positive Control</tradeName>
    <deviceName>ACCURUN 125 Anti-HBs 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>2015-0078</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:11.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020345</udiDi>
    <basicUdiDi>B-00816784020345</basicUdiDi>
    <tradeName>ACCURUN 125 Anti-HBs Positive Control</tradeName>
    <deviceName>ACCURUN 125 Anti-HBs 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>2015-0077</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:08.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020338</udiDi>
    <basicUdiDi>B-00816784020338</basicUdiDi>
    <tradeName>ACCURUN 121 HAV IgM Positive Control</tradeName>
    <deviceName>ACCURUN 121 HAV 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0076</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:07.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020321</udiDi>
    <basicUdiDi>B-00816784020321</basicUdiDi>
    <tradeName>ACCURUN 121 HAV IgM Positive Control</tradeName>
    <deviceName>ACCURUN 121 HAV 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0074</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:05.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020314</udiDi>
    <basicUdiDi>B-00816784020314</basicUdiDi>
    <tradeName>ACCURUN 120 Anti-HAV IgG</tradeName>
    <deviceName>ACCURUN 120 HAV 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0073</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:04.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020307</udiDi>
    <basicUdiDi>B-00816784020307</basicUdiDi>
    <tradeName>ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control</tradeName>
    <deviceName>ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) 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>2015-0072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:03.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020291</udiDi>
    <basicUdiDi>B-00816784020291</basicUdiDi>
    <tradeName>ACCURUN117 Hepatitis B e Antigen Positive Control</tradeName>
    <deviceName>ACCURUN117 Hepatitis B e Antigen 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>2015-0071</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:41:00.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020284</udiDi>
    <basicUdiDi>B-00816784020284</basicUdiDi>
    <tradeName>A115 Anti-HBc IgG</tradeName>
    <deviceName>A115 Anti-HBc IgG</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>2015-0070</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:59.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020277</udiDi>
    <basicUdiDi>B-00816784020277</basicUdiDi>
    <tradeName>A113 Anti-HBc IgM</tradeName>
    <deviceName>A113 Anti-HBc IgM</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>2015-0068</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:58.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020208</udiDi>
    <basicUdiDi>B-00816784020208</basicUdiDi>
    <tradeName>A52 Hepatitis Multi-Marker</tradeName>
    <deviceName>A52 Hepatitis Multi-Marker</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>2000-0043</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:47.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020192</udiDi>
    <basicUdiDi>B-00816784020192</basicUdiDi>
    <tradeName>A51 Hepatitis Multi-Marker</tradeName>
    <deviceName>A51 Hepatitis Multi-Marker</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>2000-0041</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:46.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020185</udiDi>
    <basicUdiDi>B-00816784020185</basicUdiDi>
    <tradeName>A51 Hepatitis Multi-Marker</tradeName>
    <deviceName>A51 Hepatitis Multi-Marker</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>2000-0040</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:45.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145546649</udiDi>
    <basicUdiDi>694714551045J2</basicUdiDi>
    <tradeName>MAGLUMI Anti-HAV (CLIA) Controls</tradeName>
    <deviceName>Anti-HAV (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011045MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:08.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145523152</udiDi>
    <basicUdiDi>69471455215VW</basicUdiDi>
    <tradeName>MAGLUMI HEV IgM (CLIA) Controls</tradeName>
    <deviceName>HEV IgM (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201215MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:52:44.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145523114</udiDi>
    <basicUdiDi>69471455214VU</basicUdiDi>
    <tradeName>MAGLUMI HEV IgG (CLIA) Controls</tradeName>
    <deviceName>HEV IgG (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201214MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:52:44.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590745141</udiDi>
    <basicUdiDi>150995901C39449SG</basicUdiDi>
    <tradeName>Access anti-HAV IgM QC</tradeName>
    <deviceName>Access anti-HAV IgM QC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39449</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:58.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590745110</udiDi>
    <basicUdiDi>150995901C39446SA</basicUdiDi>
    <tradeName>Access anti-HAV QC</tradeName>
    <deviceName>Access anti-HAV QC</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39446</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:56.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053070485</udiDi>
    <basicUdiDi>69449040AB74000435N</basicUdiDi>
    <tradeName>HAV IgM and HEV IgM Multi Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043941-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053070522</udiDi>
    <basicUdiDi>69449040AB74000435N</basicUdiDi>
    <tradeName>HAV IgM and HEV IgM Multi Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043944-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053070539</udiDi>
    <basicUdiDi>69449040AB74000435N</basicUdiDi>
    <tradeName>HAV IgM and HEV IgM Multi Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043942-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.209Z</lastUpdated>
  </row>
</eudamedExport>