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<eudamedExport entity="devices">
  <row>
    <udiDi>04049325008939</udiDi>
    <basicUdiDi>B-04049325008939</basicUdiDi>
    <tradeName>Fecal Helicobacter pylori-Antigen ELISA</tradeName>
    <deviceName>Fecal Helicobacter pylori-Antigen ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58891</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:11:07.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325002364</udiDi>
    <basicUdiDi>B-04049325002364</basicUdiDi>
    <tradeName>Helicobacter pylori IgM ELISA</tradeName>
    <deviceName>Helicobacter pylori IgM ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE56391</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:08:29.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325002357</udiDi>
    <basicUdiDi>B-04049325002357</basicUdiDi>
    <tradeName>Helicobacter pylori IgG ELISA</tradeName>
    <deviceName>Helicobacter pylori IgG ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE56381</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:08:28.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325002340</udiDi>
    <basicUdiDi>B-04049325002340</basicUdiDi>
    <tradeName>Helicobacter pylori IgA ELISA</tradeName>
    <deviceName>Helicobacter pylori IgA ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE56371</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:08:27.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055001217</udiDi>
    <basicUdiDi>B-04049055001217</basicUdiDi>
    <tradeName>GenoType HelicoDR VER 1.0</tradeName>
    <deviceName>GenoType HelicoDR VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>337</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:03:53.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426021143</udiDi>
    <basicUdiDi>B-00816426021143</basicUdiDi>
    <tradeName>K-ASSAY H. pylori Calibrator</tradeName>
    <deviceName>H. pylori Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-241C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:12.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426021136</udiDi>
    <basicUdiDi>B-00816426021136</basicUdiDi>
    <tradeName>K-ASSAY H. pylori</tradeName>
    <deviceName>H. pylori Test Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-240</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:08.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059070835</udiDi>
    <basicUdiDi>B-00083059070835</basicUdiDi>
    <tradeName>Hp Detect™ Stool Antigen ELISA</tradeName>
    <deviceName>HP Detect Stool Antigen ELISA</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7083</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:11.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>00083059070064</udiDi>
    <basicUdiDi>B-00083059070064</basicUdiDi>
    <tradeName>GAP IgM Helicobacter pylori ELISA</tradeName>
    <deviceName>GAP IgM Helicobacter pylori ELISA</deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:05:46.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000012807175096R2</udiDi>
    <basicUdiDi>B-000012807175096R2</basicUdiDi>
    <tradeName>Helicobacter Pylori and Toxin Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Helicobacter Pylori and Toxin Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT139</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:19.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681677201512</udiDi>
    <basicUdiDi>86816772HPJ9</basicUdiDi>
    <tradeName>HELICHECK</tradeName>
    <deviceName>RAPID UREASE TEST FOR DETECTION OF HELICOBACTER PYLORI BY LOOKING AT UREASE ACTIVITY IN BIOPSY SAMPLES</deviceName>
    <manufacturerName>Innovative Biotechnology Organization Trade Limited Company</manufacturerName>
    <manufacturerSrn>TR-MF-000037634</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010499</emdnCode>
    <emdnDescription>H. PYLORI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:33:20.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436610290104</udiDi>
    <basicUdiDi>843661029VCM10301LA</basicUdiDi>
    <tradeName>HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCM103</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:57:40.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057920720817</udiDi>
    <basicUdiDi>8057920RAPIDTESTQY</basicUdiDi>
    <tradeName>Ureasi Rapid Test</tradeName>
    <deviceName>TESTRAPIDQY</deviceName>
    <manufacturerName>Microbiol S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000052547</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010499</emdnCode>
    <emdnDescription>H. PYLORI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K.301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:52:40.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891326968</udiDi>
    <basicUdiDi>803389132CHORUSPAG007V</basicUdiDi>
    <tradeName>CHORUS HELICOBATER PYLORI Ag</tradeName>
    <deviceName>CHORUS HELICOBATER PYLORI Ag</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81063</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:19:40.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891322939</udiDi>
    <basicUdiDi>803389132CHORUSCPAGDU</basicUdiDi>
    <tradeName>CHORUS CLIA HELICOBATER PYLORI Ag</tradeName>
    <deviceName>CHORUS CLIA HELICOBATER PYLORI Ag</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:19:04.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977454210016</udiDi>
    <basicUdiDi>697745421HP01MD</basicUdiDi>
    <tradeName>06977454210016</tradeName>
    <deviceName>Helicobacter Pylori Staining Solution</deviceName>
    <manufacturerName>Guangzhou Hearty Expression Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036085</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008964</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010499</emdnCode>
    <emdnDescription>H. PYLORI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN ISO 14971</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:36:39.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977454210023</udiDi>
    <basicUdiDi>697745421HP4P</basicUdiDi>
    <tradeName>06977454210023</tradeName>
    <deviceName>Helicobacter Pylori Staining Solution</deviceName>
    <manufacturerName>Guangzhou Hearty Expression Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036085</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008964</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010499</emdnCode>
    <emdnDescription>H. PYLORI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN ISO 14971</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:36:36.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972235840045</udiDi>
    <basicUdiDi>697223584HPTSW</basicUdiDi>
    <tradeName>Helicobacter Pylori Test Kit (Urease)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026852</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010499</emdnCode>
    <emdnDescription>H. PYLORI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>LTH01-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:39:10.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095161742</udiDi>
    <basicUdiDi>4049095PM23050000JU</basicUdiDi>
    <tradeName>04049095161742</tradeName>
    <deviceName>RIDA®Prime H. pylori BDM</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM2305</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:23.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095140556</udiDi>
    <basicUdiDi>4049095N230300000UR</basicUdiDi>
    <tradeName>04049095140556</tradeName>
    <deviceName>RIDA®QUICK Helicobacter</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N2303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:50:29.214Z</lastUpdated>
  </row>
</eudamedExport>