<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+ENTIEIA-41990B</udiDi>
    <basicUdiDi>B-+ENTIEIA-41990B</basicUdiDi>
    <tradeName>+ENTIEIA-41990B</tradeName>
    <deviceName>Herpes Simplex Virus 2 IgM ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040310</emdnCode>
    <emdnDescription>HSV 2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-4199</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:40.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-41980A</udiDi>
    <basicUdiDi>B-+ENTIEIA-41980A</basicUdiDi>
    <tradeName>+ENTIEIA-41980A</tradeName>
    <deviceName>Herpes Simplex Virus 2 IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-4198</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:36.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-419709</udiDi>
    <basicUdiDi>B-+ENTIEIA-419709</basicUdiDi>
    <tradeName>+ENTIEIA-419709</tradeName>
    <deviceName>Herpes Simplex Virus 1 IgM ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040307</emdnCode>
    <emdnDescription>HSV 1 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-4197</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:35.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-419608</udiDi>
    <basicUdiDi>B-+ENTIEIA-419608</basicUdiDi>
    <tradeName>+ENTIEIA-419608</tradeName>
    <deviceName>Herpes Simplex Virus 1 IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-4196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:34.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-38690E</udiDi>
    <basicUdiDi>B-+ENTIEIA-38690E</basicUdiDi>
    <tradeName>+ENTIEIA-38690E</tradeName>
    <deviceName>Varicella-Zoster Virus (VZV) IgM ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040903</emdnCode>
    <emdnDescription>VARICELLA ZOSTER VIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3869</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:30.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-38680D</udiDi>
    <basicUdiDi>B-+ENTIEIA-38680D</basicUdiDi>
    <tradeName>+ENTIEIA-38680D</tradeName>
    <deviceName>Varicella-Zoster Virus (VZV) IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040902</emdnCode>
    <emdnDescription>VARICELLA ZOSTER VIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3868</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:29.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-38670C</udiDi>
    <basicUdiDi>B-+ENTIEIA-38670C</basicUdiDi>
    <tradeName>+ENTIEIA-38670C</tradeName>
    <deviceName>Varicella-Zoster Virus (VZV) IgA ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040999</emdnCode>
    <emdnDescription>VARICELLA ZOSTER VIRUS REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3867</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:10.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-38580C</udiDi>
    <basicUdiDi>B-+ENTIEIA-38580C</basicUdiDi>
    <tradeName>+ENTIEIA-38580C</tradeName>
    <deviceName>Rubella Virus IgM μ-capture ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040103</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3858</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:04.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-38570B</udiDi>
    <basicUdiDi>B-+ENTIEIA-38570B</basicUdiDi>
    <tradeName>+ENTIEIA-38570B</tradeName>
    <deviceName>Rubella Virus IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040102</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3857</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:03.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-385206</udiDi>
    <basicUdiDi>B-+ENTIEIA-385206</basicUdiDi>
    <tradeName>+ENTIEIA-385206</tradeName>
    <deviceName>Parvovirus B19 IgM ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040609</emdnCode>
    <emdnDescription>PARVOVIRUS B 19</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3852</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:02.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-385105</udiDi>
    <basicUdiDi>B-+ENTIEIA-385105</basicUdiDi>
    <tradeName>+ENTIEIA-385105</tradeName>
    <deviceName>Parvovirus B19 IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040609</emdnCode>
    <emdnDescription>PARVOVIRUS B 19</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3851</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:01.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-384508</udiDi>
    <basicUdiDi>B-+ENTIEIA-384508</basicUdiDi>
    <tradeName>+ENTIEIA-384508</tradeName>
    <deviceName>Measles Virus IgM ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040703</emdnCode>
    <emdnDescription>MEASLES VIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3845</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:57.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-384407</udiDi>
    <basicUdiDi>B-+ENTIEIA-384407</basicUdiDi>
    <tradeName>+ENTIEIA-384407</tradeName>
    <deviceName>Measles Virus IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040702</emdnCode>
    <emdnDescription>MEASLES VIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3844</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:57.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-384003</udiDi>
    <basicUdiDi>B-+ENTIEIA-384003</basicUdiDi>
    <tradeName>+ENTIEIA-384003</tradeName>
    <deviceName>Herpes Simplex Virus 1+2 IgM ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3840</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:55.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-38390B</udiDi>
    <basicUdiDi>B-+ENTIEIA-38390B</basicUdiDi>
    <tradeName>+ENTIEIA-38390B</tradeName>
    <deviceName>Herpes Simplex Virus 1+2 IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3839</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:51.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-382304</udiDi>
    <basicUdiDi>B-+ENTIEIA-382304</basicUdiDi>
    <tradeName>+ENTIEIA-382304</tradeName>
    <deviceName>Cytomegalovirus (CMV) IgM ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3823</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:50.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-380807</udiDi>
    <basicUdiDi>B-+ENTIEIA-380807</basicUdiDi>
    <tradeName>+ENTIEIA-380807</tradeName>
    <deviceName>Cytomegalovirus (CMV) IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040203</emdnCode>
    <emdnDescription>CMV IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3808</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:44.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEBVM0150DS0Z</udiDi>
    <basicUdiDi>B-+ENTIEBVM0150DS0Z</basicUdiDi>
    <tradeName>+ENTIEBVM0150DS0Z</tradeName>
    <deviceName>NovaLisa® Epstein-Barr Virus (VCA) IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040104</emdnCode>
    <emdnDescription>EBV VCA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBVM0150DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:38.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEBVM01500.</udiDi>
    <basicUdiDi>B-+ENTIEBVM01500.</basicUdiDi>
    <tradeName>+ENTIEBVM01500.</tradeName>
    <deviceName>NovaLisa® Epstein-Barr Virus (VCA) IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040104</emdnCode>
    <emdnDescription>EBV VCA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBVM0150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:37.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEBVG0580DS0-</udiDi>
    <basicUdiDi>B-+ENTIEBVG0580DS0-</basicUdiDi>
    <tradeName>+ENTIEBVG0580DS0-</tradeName>
    <deviceName>NovaLisa® Epstein-Barr Virus (EBNA) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBVG0580DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:37.175Z</lastUpdated>
  </row>
</eudamedExport>