<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-7187BT</udiDi>
    <basicUdiDi>B-7187BT</basicUdiDi>
    <tradeName>Bioeurope 4 Food Intolerance Test (ref:7187)</tradeName>
    <deviceName>Bioeurope 4 Food Intolerance Test (ref:7187)</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>7187</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:47.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7184BM</udiDi>
    <basicUdiDi>B-7184BM</basicUdiDi>
    <tradeName>Bioeurope 4 Food Intolerance Test (ref:7184)</tradeName>
    <deviceName>Bioeurope 4 Food Intolerance Test (ref:7184)</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>7184</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:36.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7182BH</udiDi>
    <basicUdiDi>B-7182BH</basicUdiDi>
    <tradeName>Bioeurope 14 Food Intolerance Test (ref:7182)</tradeName>
    <deviceName>Bioeurope 14 Food Intolerance Test (ref:7182)</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>7182</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:32.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7181BF</udiDi>
    <basicUdiDi>B-7181BF</basicUdiDi>
    <tradeName>Bioeurope 7 Food Intolerance Test (ref:7181)</tradeName>
    <deviceName>Bioeurope 7 Food Intolerance Test (ref:7181)</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>7181</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:29.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7180BD</udiDi>
    <basicUdiDi>B-7180BD</basicUdiDi>
    <tradeName>Bioeurope 90 Food Intolernace Test (ref:7180)</tradeName>
    <deviceName>Bioeurope 90 Food Intolerance Test (ref:7180)</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>7180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:30:28.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414966793</udiDi>
    <basicUdiDi>0405686901365VM</basicUdiDi>
    <tradeName>IMMULITE 2000 Allergen-Specific  IgG4</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_Allergen-Specific IgG4</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380879</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:55.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414966786</udiDi>
    <basicUdiDi>0405686901366VP</basicUdiDi>
    <tradeName>IMMULITE 2000 Allergy Specific IgG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_Allergy Specific IgG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380880</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:54.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059071948</udiDi>
    <basicUdiDi>00830597194JN</basicUdiDi>
    <tradeName>NutriDetect™ 14G A ELISA</tradeName>
    <deviceName>NutriDetect™ 14G A ELISA</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7194</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:30.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059071931</udiDi>
    <basicUdiDi>00830597193JL</basicUdiDi>
    <tradeName>NutriDetect™ 90G R IgG ELISA</tradeName>
    <deviceName>NutriDetect™ 90G R IgG ELISA</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7193</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:28.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059071825</udiDi>
    <basicUdiDi>00830597182JF</basicUdiDi>
    <tradeName>NutriDetect™ 14G B ELISA</tradeName>
    <deviceName>NutriDetect™ 14G B ELISA</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7182</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:25.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059071795</udiDi>
    <basicUdiDi>00830597179JS</basicUdiDi>
    <tradeName>NutriDetect™ 42G A ELISA</tradeName>
    <deviceName>NutriDetect™ 42G A IgG ELISA</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7179</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:24.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059071818</udiDi>
    <basicUdiDi>00830597181JD</basicUdiDi>
    <tradeName>NutriDetect™ 7G B IgG ELISA</tradeName>
    <deviceName>NutriDetect™ 7G B IgG ELISA</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7181</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:24.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059071801</udiDi>
    <basicUdiDi>00830597180JB</basicUdiDi>
    <tradeName>NutriDetect™ 90G B IgG ELISA</tradeName>
    <deviceName>NutriDetect™ 90G B IgG ELISA</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:23.300Z</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>
</eudamedExport>