<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IgE706-AEAC</udiDi>
    <basicUdiDi>B-IgE706-AEAC</basicUdiDi>
    <tradeName>TIgE Total Immunoglobulin E (CLIA)</tradeName>
    <deviceName>TIgE Total Immunoglobulin E (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IgE706-AE10Y, IgE706-AE10N, IgE706-AE20Y, IgE706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:43.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILR-E02XC</udiDi>
    <basicUdiDi>B-ILR-E02XC</basicUdiDi>
    <tradeName>Specific IgE RIA</tradeName>
    <deviceName>Specific IgE RIA</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>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILR-E02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:34.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILR-E01XA</udiDi>
    <basicUdiDi>B-ILR-E01XA</basicUdiDi>
    <tradeName>ILR-E01XA</tradeName>
    <deviceName>Tracer IgE</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>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILR-E01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:33.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG959U</udiDi>
    <basicUdiDi>B-ILE-SCG959U</basicUdiDi>
    <tradeName>ILE-SCG959U</tradeName>
    <deviceName>IgG4 Screen Nutritional LDW278 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-SCG95</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:32.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG689R</udiDi>
    <basicUdiDi>B-ILE-SCG689R</basicUdiDi>
    <tradeName>ILE-SCG689R</tradeName>
    <deviceName>IgG Screen Select 7 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-SCG68</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:31.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG679P</udiDi>
    <basicUdiDi>B-ILE-SCG679P</basicUdiDi>
    <tradeName>ILE-SCG679P</tradeName>
    <deviceName>IgG Screen Select 6 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-SCG67</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:27.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG669M</udiDi>
    <basicUdiDi>B-ILE-SCG669M</basicUdiDi>
    <tradeName>ILE-SCG669M</tradeName>
    <deviceName>IgG Screen Select 5 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-SCG66</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:26.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG659K</udiDi>
    <basicUdiDi>B-ILE-SCG659K</basicUdiDi>
    <tradeName>ILE-SCG659K</tradeName>
    <deviceName>IgG Screen Select 4 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-SCG65</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:26.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG2323S</udiDi>
    <basicUdiDi>B-ILE-SCG2323S</basicUdiDi>
    <tradeName>ILE-SCG2323S</tradeName>
    <deviceName>IgG4 Screen Nutritional K44 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-SCG232</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:25.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>ILE-SCG2313Q</udiDi>
    <basicUdiDi>B-ILE-SCG2313Q</basicUdiDi>
    <tradeName>ILE-SCG2313Q</tradeName>
    <deviceName>IgG4 Screen Mediterranean 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-SCG231</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:20:21.383Z</lastUpdated>
  </row>
  <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>
</eudamedExport>