<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04260702150137</udiDi>
    <basicUdiDi>B-04260702150137</basicUdiDi>
    <tradeName>preOx - HUT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>preOx.RS GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005017</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200.070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T01:15:40.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260702150120</udiDi>
    <basicUdiDi>B-04260702150120</basicUdiDi>
    <tradeName>preOx - HUT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>preOx.RS GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005017</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200.060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T01:15:39.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260702150113</udiDi>
    <basicUdiDi>B-04260702150113</basicUdiDi>
    <tradeName>preOx - HUT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>preOx.RS GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005017</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200.050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T01:15:39.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551989</udiDi>
    <basicUdiDi>B-04260658551989</basicUdiDi>
    <tradeName>Atlas</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.04.24.1.0025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:47.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551972</udiDi>
    <basicUdiDi>B-04260658551972</basicUdiDi>
    <tradeName>Atlas</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.04.23.1.0020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:46.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975156250811</udiDi>
    <basicUdiDi>6975156250000DZF</basicUdiDi>
    <tradeName>H.Pylori Antibody Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Tongzhou Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038774</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I021-N4002T-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:31.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975156250903</udiDi>
    <basicUdiDi>6975156250000DZF</basicUdiDi>
    <tradeName>H.Pylori Antibody Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Tongzhou Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038774</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I021-N4002-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:31.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975156250910</udiDi>
    <basicUdiDi>6975156250000DZF</basicUdiDi>
    <tradeName>H.Pylori Antibody Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Tongzhou Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038774</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I021-N4002-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:31.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>08429577004846</udiDi>
    <basicUdiDi>84295779231XW</basicUdiDi>
    <tradeName>Simple H.pyl-Tf</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.231.020.71.000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:56:25.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>08429577007823</udiDi>
    <basicUdiDi>84295779231XW</basicUdiDi>
    <tradeName>VIRAPID® HELICOBACTER PYLORI/TRANSFERRIN Ag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.23.1025.62.026 -</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:56:25.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>08429577007854</udiDi>
    <basicUdiDi>84295779231XW</basicUdiDi>
    <tradeName>Simple H.pyl-Tf</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.231.020.15.000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:56:25.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>08429577007861</udiDi>
    <basicUdiDi>84295779231XW</basicUdiDi>
    <tradeName>Simple H.pyl-Tf</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.231.020.16.000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:56:25.129Z</lastUpdated>
  </row>
</eudamedExport>