<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-LBL417A</udiDi>
    <basicUdiDi>B-ILE-LBL417A</basicUdiDi>
    <tradeName>ILE-LBL417A</tradeName>
    <deviceName>LINEBLOT IGE US9</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>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:37.335Z</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-ILE-LBL4078</udiDi>
    <basicUdiDi>B-ILE-LBL4078</basicUdiDi>
    <tradeName>D-ILE-LBL4078</tradeName>
    <deviceName>LINEBLOT IGE US8</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>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:22.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILE-LBL397P</udiDi>
    <basicUdiDi>B-ILE-LBL397P</basicUdiDi>
    <tradeName>D-ILE-LBL397P</tradeName>
    <deviceName>LINEBLOT IGE US7</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>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL39</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:20.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILE-LBL387M</udiDi>
    <basicUdiDi>B-ILE-LBL387M</basicUdiDi>
    <tradeName>D-ILE-LBL387M</tradeName>
    <deviceName>LINEBLOT IGE US6</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>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-LBL38</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:19.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-I0235NK</udiDi>
    <basicUdiDi>B-I0235NK</basicUdiDi>
    <tradeName>Immunoglobulin E (IgE)</tradeName>
    <deviceName>Immunoglobulin E (IgE)</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0235</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:03:11.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD194XZ</udiDi>
    <basicUdiDi>B-GKPD194XZ</basicUdiDi>
    <tradeName>IgE Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>IgE Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD194</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:13.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GGIGE-302aX2</udiDi>
    <basicUdiDi>B-GGIGE-302aX2</basicUdiDi>
    <tradeName>Total IgE Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Total IgE Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGIGE-302a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:17.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GGIGE-302aHGV2</udiDi>
    <basicUdiDi>B-GGIGE-302aHGV2</basicUdiDi>
    <tradeName>Total IgE Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Total IgE Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGIGE-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:14.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FGIGE-302aW5</udiDi>
    <basicUdiDi>B-FGIGE-302aW5</basicUdiDi>
    <tradeName>IgE Quantitative Test Kit(Time-Resolved FIA)</tradeName>
    <deviceName>IgE Quantitative Test Kit(Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FGIGE-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:16.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FGIGE-302aHGTV</udiDi>
    <basicUdiDi>B-FGIGE-302aHGTV</basicUdiDi>
    <tradeName>IgE Quantitative Test Kit(Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FGIGE-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:15.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01557G</udiDi>
    <basicUdiDi>B-DT01557G</basicUdiDi>
    <tradeName>Unicorn-Total IgE</tradeName>
    <deviceName>Unicorn-Total IgE</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DT0155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:16:51.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT01547E</udiDi>
    <basicUdiDi>B-DT01547E</basicUdiDi>
    <tradeName>Unicorn-Total IgE</tradeName>
    <deviceName>Unicorn-Total IgE</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DT0154</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:16:49.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76383G8</udiDi>
    <basicUdiDi>B-DC76383G8</basicUdiDi>
    <tradeName>iStar- Total IgE</tradeName>
    <deviceName>iStar- Total IgE</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76383</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:40.114Z</lastUpdated>
  </row>
</eudamedExport>