<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>ILE-SCG2203K</udiDi>
    <basicUdiDi>B-ILE-SCG2203K</basicUdiDi>
    <tradeName>ILE-SCG2203K</tradeName>
    <deviceName>FINTEST IGG4 (90) KOREA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:20.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG2113J</udiDi>
    <basicUdiDi>B-ILE-SCG2113J</basicUdiDi>
    <tradeName>ILE-SCG2113J</tradeName>
    <deviceName>IgG4 Screen Nutritional I 2 90 ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:19.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG1513R</udiDi>
    <basicUdiDi>B-ILE-SCG1513R</basicUdiDi>
    <tradeName>ILE-SCG1513R</tradeName>
    <deviceName>IgG Screen Nutritional 40 ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:18.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG1503P</udiDi>
    <basicUdiDi>B-ILE-SCG1503P</basicUdiDi>
    <tradeName>ILE-SCG1503P</tradeName>
    <deviceName>IgG Screen Nutritional 24 ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:14.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG141TW68</udiDi>
    <basicUdiDi>B-ILE-SCG141TW68</basicUdiDi>
    <tradeName>ILE-SCG141TW68</tradeName>
    <deviceName>IgG4 Screen Nutritional TW88 ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG141</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:14.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG140TW63</udiDi>
    <basicUdiDi>B-ILE-SCG140TW63</basicUdiDi>
    <tradeName>ILE-SCG140TW63</tradeName>
    <deviceName>IgG4 Screen Nutritional TW22 ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILS-SCG140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:13.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG1153M</udiDi>
    <basicUdiDi>B-ILE-SCG1153M</basicUdiDi>
    <tradeName>ILE-SCG1153M</tradeName>
    <deviceName>IgG Screen Nutritional 44 IN ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:12.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG0693</udiDi>
    <basicUdiDi>B-ILE-SCG0693</basicUdiDi>
    <tradeName>ILE-SCG0693</tradeName>
    <deviceName>IgG4 Screen Nutritional 20 ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:19:57.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILE-SCG10038</udiDi>
    <basicUdiDi>B-ILE-SCG10038</basicUdiDi>
    <tradeName>D-ILE-SCG10038</tradeName>
    <deviceName>IGG SCREEN  N 44</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:13.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILE-SCG058Z</udiDi>
    <basicUdiDi>B-ILE-SCG058Z</basicUdiDi>
    <tradeName>D-ILE-SCG058Z</tradeName>
    <deviceName>ALLERGO PLUS2 IGG4</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:09.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILE-SCG048X</udiDi>
    <basicUdiDi>B-ILE-SCG048X</basicUdiDi>
    <tradeName>D-ILE-SCG048X</tradeName>
    <deviceName>ALLERGO PLUS1 IGG4</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:08.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILE-SCG038V</udiDi>
    <basicUdiDi>B-ILE-SCG038V</basicUdiDi>
    <tradeName>D-ILE-SCG038V</tradeName>
    <deviceName>BASIC SCREEN IGG4</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:07.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILE-SCG018R</udiDi>
    <basicUdiDi>B-ILE-SCG018R</basicUdiDi>
    <tradeName>D-ILE-SCG018R</tradeName>
    <deviceName>SCREEN IGG4</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-SCG01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:07.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-LBL1375</udiDi>
    <basicUdiDi>B-ILE-LBL1375</basicUdiDi>
    <tradeName>ILE-LBL1375</tradeName>
    <deviceName>immunoLINE IgG4 MX3</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:36.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-LBL1273</udiDi>
    <basicUdiDi>B-ILE-LBL1273</basicUdiDi>
    <tradeName>ILE-LBL1273</tradeName>
    <deviceName>immunoLINE IgG4 MX2</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILI-LBL12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:34.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-LBL116Z</udiDi>
    <basicUdiDi>B-ILE-LBL116Z</basicUdiDi>
    <tradeName>ILE-LBL116Z</tradeName>
    <deviceName>immunoLINE IgG4 MX1</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:33.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-LBL106X</udiDi>
    <basicUdiDi>B-ILE-LBL106X</basicUdiDi>
    <tradeName>ILE-LBL106X</tradeName>
    <deviceName>immunoLINE IgG4 Nutritional</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:32.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AL5154ZR44EA</udiDi>
    <basicUdiDi>B-AL5154ZR44EA</basicUdiDi>
    <tradeName>AccuDiag™ Human Specific IgG 88 Food Allergens</tradeName>
    <deviceName>AccuDiag™ Human Specific IgG 88 Food Allergens</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5154-8</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:34:36.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>42623675671946</udiDi>
    <basicUdiDi>B-42623675671946</basicUdiDi>
    <tradeName>Bioeurope 14 Food Intolerance Test (ref:7194)</tradeName>
    <deviceName>Bioeurope 14 Food Intolerance Test (ref:7194)</deviceName>
    <manufacturerName>BIOEUROPE GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000039230</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7194</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:36:16.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>42623675671892</udiDi>
    <basicUdiDi>B-42623675671892</basicUdiDi>
    <tradeName>Bioeurope 7 Food Intolerance Test (ref:7189)</tradeName>
    <deviceName>Bioeurope 7 Food Intolerance Test (ref:7189)</deviceName>
    <manufacturerName>BIOEUROPE GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000039230</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7189</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:36:15.525Z</lastUpdated>
  </row>
</eudamedExport>