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<eudamedExport entity="devices">
  <row>
    <udiDi>05391516747073</udiDi>
    <basicUdiDi>B-05391516747073</basicUdiDi>
    <tradeName>Captia EBV VCA IgG Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2325700</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:29:35.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516746557</udiDi>
    <basicUdiDi>B-05391516746557</basicUdiDi>
    <tradeName>Platelia EBV-VCA IgG Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72937</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:35.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516743556</udiDi>
    <basicUdiDi>B-05391516743556</basicUdiDi>
    <tradeName>Captia EBV-VCA IgM Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2325760</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:35.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516746540</udiDi>
    <basicUdiDi>B-05391516746540</basicUdiDi>
    <tradeName>Platelia EBV-VCA IgM Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72936</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:34.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516747080</udiDi>
    <basicUdiDi>B-05391516747080</basicUdiDi>
    <tradeName>Captia EBV-VCA IgM Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2325761</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:34.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516747240</udiDi>
    <basicUdiDi>B-05391516747240</basicUdiDi>
    <tradeName>ACE Control-E</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:34.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516747233</udiDi>
    <basicUdiDi>B-05391516747233</basicUdiDi>
    <tradeName>ACE Control-N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A6040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:15.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516741545</udiDi>
    <basicUdiDi>B-05391516741545</basicUdiDi>
    <tradeName>ACE Calibrator 30550</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30550</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:15.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516743136</udiDi>
    <basicUdiDi>B-05391516743136</basicUdiDi>
    <tradeName>G-6-PDH Control, Intermediate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G5029</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:15.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516743143</udiDi>
    <basicUdiDi>B-05391516743143</basicUdiDi>
    <tradeName>G-6-PDH Control, Deficient</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G5888</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:14.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516743150</udiDi>
    <basicUdiDi>B-05391516743150</basicUdiDi>
    <tradeName>G-6-PDH Control, Normal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G6888</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:14.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850048690400</udiDi>
    <basicUdiDi>B-00850048690400</basicUdiDi>
    <tradeName>Captia™ Cytomegalovirus IgM kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2325260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:14.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850048690424</udiDi>
    <basicUdiDi>B-00850048690424</basicUdiDi>
    <tradeName>Captia™ Cytomegalovirus IgM kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2325261</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T14:28:14.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516745048</udiDi>
    <basicUdiDi>B-05391516745048</basicUdiDi>
    <tradeName>Captia NMT Syphilis IgM EIA</tradeName>
    <deviceName>Captia NMT Syphilis IgM EIA (96 Tests)</deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010304</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2329360</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:47:22.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516745123</udiDi>
    <basicUdiDi>B-05391516745123</basicUdiDi>
    <tradeName>Captia™ Malaria EIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2322470 / 2322471</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:35:22.817Z</lastUpdated>
  </row>
</eudamedExport>