<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+ENTIRE587010F</udiDi>
    <basicUdiDi>B-+ENTIRE587010F</basicUdiDi>
    <tradeName>+ENTIRE587010F</tradeName>
    <deviceName>Ascaris lumbricoides 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>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:13.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIRE586910N</udiDi>
    <basicUdiDi>B-+ENTIRE586910N</basicUdiDi>
    <tradeName>+ENTIRE586910N</tradeName>
    <deviceName>Chagas (Trypanosoma cruzi) 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>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58691</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:12.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIRE586410I</udiDi>
    <basicUdiDi>B-+ENTIRE586410I</basicUdiDi>
    <tradeName>+ENTIRE586410I</tradeName>
    <deviceName>Leishmania infantum 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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58641</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:06.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIRE586310H</udiDi>
    <basicUdiDi>B-+ENTIRE586310H</basicUdiDi>
    <tradeName>+ENTIRE586310H</tradeName>
    <deviceName>Entamoeba histolytica 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>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58631</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:06.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIMAL0620DS0C</udiDi>
    <basicUdiDi>B-+ENTIMAL0620DS0C</basicUdiDi>
    <tradeName>+ENTIMAL0620DS0C</tradeName>
    <deviceName>NovaLisa® Malaria</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>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL0620DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:15:39.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIMAL06200E</udiDi>
    <basicUdiDi>B-+ENTIMAL06200E</basicUdiDi>
    <tradeName>+ENTIMAL06200E</tradeName>
    <deviceName>NovaLisa® Malaria</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>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL0620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:15:37.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTILEIG0310DS0O</udiDi>
    <basicUdiDi>B-+ENTILEIG0310DS0O</basicUdiDi>
    <tradeName>+ENTILEIG0310DS0O</tradeName>
    <deviceName>NovaLisa® Leishmania infantum 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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEIG0310DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:15:31.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTILEIG03100Q</udiDi>
    <basicUdiDi>B-+ENTILEIG03100Q</basicUdiDi>
    <tradeName>+ENTILEIG03100Q</tradeName>
    <deviceName>NovaLisa® Leishmania infantum 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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEIG0310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:15:15.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIFIL0760DS0I</udiDi>
    <basicUdiDi>B-+ENTIFIL0760DS0I</basicUdiDi>
    <tradeName>+ENTIFIL0760DS0I</tradeName>
    <deviceName>NovaLisa® Filariasis</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>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIL0760DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:01.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIFIL07600K</udiDi>
    <basicUdiDi>B-+ENTIFIL07600K</basicUdiDi>
    <tradeName>+ENTIFIL07600K</tradeName>
    <deviceName>NovaLisa® Filariasis</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>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIL0760</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:00.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIENTG0140DS0_</udiDi>
    <basicUdiDi>B-+ENTIENTG0140DS0_</basicUdiDi>
    <tradeName>+ENTIENTG0140DS0_</tradeName>
    <deviceName>NovaLisa® Entamoeba histolytica 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>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENTG0140DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:59.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIENTG01400/</udiDi>
    <basicUdiDi>B-+ENTIENTG01400/</basicUdiDi>
    <tradeName>+ENTIENTG01400/</tradeName>
    <deviceName>NovaLisa® Entamoeba histolytica 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>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENTG0140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:55.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-581305</udiDi>
    <basicUdiDi>B-+ENTIEIA-581305</basicUdiDi>
    <tradeName>+ENTIEIA-581305</tradeName>
    <deviceName>Chagas (Trypanosoma cruzi) 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>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-5813</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:47.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-551100</udiDi>
    <basicUdiDi>B-+ENTIEIA-551100</basicUdiDi>
    <tradeName>+ENTIEIA-551100</tradeName>
    <deviceName>Malaria 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>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-5511</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:46.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-384306</udiDi>
    <basicUdiDi>B-+ENTIEIA-384306</basicUdiDi>
    <tradeName>+ENTIEIA-384306</tradeName>
    <deviceName>Leishmania infantum 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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3843</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:56.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIECHG0130DS0E</udiDi>
    <basicUdiDi>B-+ENTIECHG0130DS0E</basicUdiDi>
    <tradeName>+ENTIECHG0130DS0E</tradeName>
    <deviceName>NovaLisa® Echinococcus 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>W0105050204</emdnCode>
    <emdnDescription>ECHINOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECHG0130DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:43.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIECHG01300G</udiDi>
    <basicUdiDi>B-+ENTIECHG01300G</basicUdiDi>
    <tradeName>+ENTIECHG01300G</tradeName>
    <deviceName>NovaLisa® Echinococcus 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>W0105050204</emdnCode>
    <emdnDescription>ECHINOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECHG0130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:42.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDENO01140X</udiDi>
    <basicUdiDi>B-+ENTIDENO01140X</basicUdiDi>
    <tradeName>+ENTIDENO01140X</tradeName>
    <deviceName>Chagas (Trypanosoma cruzi) 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>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DENO0114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:32.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDEIG03100I</udiDi>
    <basicUdiDi>B-+ENTIDEIG03100I</basicUdiDi>
    <tradeName>+ENTIDEIG03100I</tradeName>
    <deviceName>Leishmania infantum 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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEIG0310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:08.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICHAG0560DS0H</udiDi>
    <basicUdiDi>B-+ENTICHAG0560DS0H</basicUdiDi>
    <tradeName>+ENTICHAG0560DS0H</tradeName>
    <deviceName>NovaLisa® Chagas (Trypanosoma cruzi) 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>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHAG0560DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:09:50.673Z</lastUpdated>
  </row>
</eudamedExport>