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<eudamedExport entity="devices">
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    <udiDi>00850075957026</udiDi>
    <basicUdiDi>0816784020121XN</basicUdiDi>
    <tradeName>Optitrol HSV 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13037</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:54:57.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956739</udiDi>
    <basicUdiDi>0816784020122XQ</basicUdiDi>
    <tradeName>Optitrol Measles M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR15045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:54:49.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956456</udiDi>
    <basicUdiDi>0816784020122XQ</basicUdiDi>
    <tradeName>Optitrol Measles M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR15048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:54:49.931Z</lastUpdated>
  </row>
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    <udiDi>00850075956487</udiDi>
    <basicUdiDi>0816784020123XS</basicUdiDi>
    <tradeName>Optitrol Parvo M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR15057</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:54:49.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956470</udiDi>
    <basicUdiDi>0816784020123XS</basicUdiDi>
    <tradeName>Optitrol Parvo M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR15058</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:54:49.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956746</udiDi>
    <basicUdiDi>0816784020124XU</basicUdiDi>
    <tradeName>Optitrol VZV M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR15078</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:54:49.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956722</udiDi>
    <basicUdiDi>0816784020124XU</basicUdiDi>
    <tradeName>Optitrol VZV M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR15077</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:54:49.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075957156</udiDi>
    <basicUdiDi>0816784020132XT</basicUdiDi>
    <tradeName>Optitrol Lyme/TBE M</tradeName>
    <deviceName>Optitrol Lyme/TBE M</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR17025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:51:02.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075957125</udiDi>
    <basicUdiDi>0816784020126XY</basicUdiDi>
    <tradeName>Optitrol Lyme/TBE G</tradeName>
    <deviceName>Optitrol Lyme/TBE G</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR17015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:50:58.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956555</udiDi>
    <basicUdiDi>0816784020120XL</basicUdiDi>
    <tradeName>Optitrol Syphilis G</tradeName>
    <deviceName>Optitrol Syphilis G</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11135</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:50:56.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075957149</udiDi>
    <basicUdiDi>0816784020126XY</basicUdiDi>
    <tradeName>Optitrol Lyme/TBE G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR17018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:35.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075957132</udiDi>
    <basicUdiDi>0816784020126XY</basicUdiDi>
    <tradeName>Optitrol Lyme/TBE G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR17017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:34.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075957170</udiDi>
    <basicUdiDi>0816784020132XT</basicUdiDi>
    <tradeName>Optitrol Lyme/TBE M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR17028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:34.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075957163</udiDi>
    <basicUdiDi>0816784020132XT</basicUdiDi>
    <tradeName>Optitrol Lyme/TBE M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR17027</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:34.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850075956562</udiDi>
    <basicUdiDi>0816784020120XL</basicUdiDi>
    <tradeName>Optitrol Syphilis G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11137</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:34.308Z</lastUpdated>
  </row>
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    <udiDi>00850075956630</udiDi>
    <basicUdiDi>0816784020130XP</basicUdiDi>
    <tradeName>Optitrol ToRCH M Pos</tradeName>
    <deviceName>Optitrol ToRCH M Pos</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13027</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:23.563Z</lastUpdated>
  </row>
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    <udiDi>00850075956647</udiDi>
    <basicUdiDi>0816784020130XP</basicUdiDi>
    <tradeName>Optitrol ToRCH M Pos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13029</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:08.433Z</lastUpdated>
  </row>
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    <udiDi>00850075956661</udiDi>
    <basicUdiDi>0816784020130XP</basicUdiDi>
    <tradeName>Optitrol ToRCH M Neg</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13057</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:04.407Z</lastUpdated>
  </row>
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    <udiDi>08056771104050</udiDi>
    <basicUdiDi>80567713115614J</basicUdiDi>
    <tradeName>LIAISON® Biotrin Control Parvovirus B19 IgM Plus</tradeName>
    <deviceName>LIAISON® Biotrin Control Parvovirus B19 IgM Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311561</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:49.820Z</lastUpdated>
  </row>
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    <udiDi>08056771104012</udiDi>
    <basicUdiDi>80567713115414C</basicUdiDi>
    <tradeName>LIAISON® Biotrin Control Parvovirus B19 IgG Plus</tradeName>
    <deviceName>LIAISON® Biotrin Control Parvovirus B19 IgG Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311541</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:48.220Z</lastUpdated>
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