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<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76382G6</udiDi>
    <basicUdiDi>B-DC76382G6</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>DC76382</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:39.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76381G4</udiDi>
    <basicUdiDi>B-DC76381G4</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>DC76381</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:35.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76106FC</udiDi>
    <basicUdiDi>B-DC76106FC</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>DC76106</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:04:48.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76104F8</udiDi>
    <basicUdiDi>B-DC76104F8</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>DC76104</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:04:46.561Z</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>D-AB5150ZR445Q</udiDi>
    <basicUdiDi>B-AB5150ZR445Q</basicUdiDi>
    <tradeName>AccuDiag™ Human Specific IgE (20 Seasonal Allergens)</tradeName>
    <deviceName>AccuDiag™ Human Specific IgE (20 Seasonal 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>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5150-8</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:17:37.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M08FC</udiDi>
    <basicUdiDi>B-7M08FC</basicUdiDi>
    <tradeName>Immunoglobulin E assay (CLIA)</tradeName>
    <deviceName>Immunoglobulin E assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</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>7M08V1-B-EU, 7M08U1-B-EU, 7M08P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:35.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-474620QQ</udiDi>
    <basicUdiDi>B-474620QQ</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>474620</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:04:25.856Z</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>
  <row>
    <udiDi>42623675671793</udiDi>
    <basicUdiDi>B-42623675671793</basicUdiDi>
    <tradeName>Bioeurope 42 Food Intolerance Test (ref:7179)</tradeName>
    <deviceName>Bioeurope 42 Food Intolerance Test (ref:7179)</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>7179</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:36:11.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277936012B</udiDi>
    <basicUdiDi>B-37700277936012B</basicUdiDi>
    <tradeName>PEO WB IgG</tradeName>
    <deviceName>PEO WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEO-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:33.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-377002779359539</udiDi>
    <basicUdiDi>B-377002779359539</basicUdiDi>
    <tradeName>PEO WB IgG</tradeName>
    <deviceName>PEO WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEO-WB24G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:31.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277935883C</udiDi>
    <basicUdiDi>B-37700277935883C</basicUdiDi>
    <tradeName>PEO WB IgG</tradeName>
    <deviceName>PEO WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEO-WB12G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:29.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-377002779339733</udiDi>
    <basicUdiDi>B-377002779339733</basicUdiDi>
    <tradeName>PEO ICT IgG-IgM</tradeName>
    <deviceName>PEO ICT IgG-IgM</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPEO Ab ICT100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:01.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277933802J</udiDi>
    <basicUdiDi>B-37700277933802J</basicUdiDi>
    <tradeName>PEO ICT IgG-IgM</tradeName>
    <deviceName>PEO ICT IgG-IgM</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020299</emdnCode>
    <emdnDescription>ALLERGY TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPEO Ab ICT20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:56:56.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3073AF</udiDi>
    <basicUdiDi>B-3073AF</basicUdiDi>
    <tradeName>D-3073AF</tradeName>
    <deviceName>Total IgE in vitro diagnostic kit (Chemiluminescent immunoassay)</deviceName>
    <manufacturerName>Aikang Diagnostics Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028962</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKBR3073030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:16:34.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120122920251</udiDi>
    <basicUdiDi>91201229202JQ</basicUdiDi>
    <tradeName>09120122920251</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02-5001-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:57:31.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120122920350</udiDi>
    <basicUdiDi>91201229203JS</basicUdiDi>
    <tradeName>09120122920350</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03-5001-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:57:31.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719748</udiDi>
    <basicUdiDi>692591270270HG</basicUdiDi>
    <tradeName>iFlash-Total IgE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86285E-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:12.251Z</lastUpdated>
  </row>
</eudamedExport>