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<eudamedExport entity="devices">
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    <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>EVIRTVCMDK1</udiDi>
    <basicUdiDi>++EVIRSyphilisIgMKitDC</basicUdiDi>
    <tradeName>Treponema + VDRL ViraChip IgM Deca Kit</tradeName>
    <deviceName>Treponema + VDRL ViraChip IgM Test Kit</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010304</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-TVCMDK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:23.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRTVCMAC1</udiDi>
    <basicUdiDi>++EVIRSyphilisIgMABRQ</basicUdiDi>
    <tradeName>Treponema + VDRL ViraChip IgM Antigen Coated Wells</tradeName>
    <deviceName>Treponema + VDRL ViraChip IgM Antigen Coated Wells</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010304</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-TVCMAC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:21.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050616040909</udiDi>
    <basicUdiDi>B-08050616040909</basicUdiDi>
    <tradeName>SYPH IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000029123</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010304</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIM.CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:10:20.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0270152VK</udiDi>
    <basicUdiDi>B-0270152VK</basicUdiDi>
    <tradeName>Syphilis Test</tradeName>
    <deviceName>Syphilis Test</deviceName>
    <manufacturerName>möLab GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022941</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010304</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0270152</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:24:28.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRTVCMOK1</udiDi>
    <basicUdiDi>++EVIRSyphilisIgMKitDC</basicUdiDi>
    <tradeName>Treponema + VDRL ViraChip IgM Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010304</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-TVCMOK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:06:23.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRTVCMRT1</udiDi>
    <basicUdiDi>++EVIRSyphilisIgMABRQ</basicUdiDi>
    <tradeName>Treponema + VDRL ViraChip IgM Antigen Coated Wells (8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010304</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-TVCMRT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:06:23.763Z</lastUpdated>
  </row>
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