<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05944759080003</udiDi>
    <basicUdiDi>5944759080VTHPG25STO1B6H5</basicUdiDi>
    <tradeName>TEST RAPID H. PYLORI ANTIGEN CASETA(SCAUN)</tradeName>
    <deviceName>HELICOBACTER PYLORI AG RAPID TEST CASSETTE (FECES)</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</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>VT-HPG-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:23.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598015456</udiDi>
    <basicUdiDi>B-04050598015456</basicUdiDi>
    <tradeName>PreventID® H. pylori</tradeName>
    <deviceName>PreventID® H. pylori</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</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>KST18116GP.05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:38.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384171736</udiDi>
    <basicUdiDi>5032384RapIDHpStARE3</basicUdiDi>
    <tradeName>RAPID HP STAR LATERAL FLOW KIT</tradeName>
    <deviceName>RAPID HP STAR LATERAL FLOW KIT</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K671411-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:09.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384171811</udiDi>
    <basicUdiDi>5032384IdeiaHpStarZ6</basicUdiDi>
    <tradeName>AMPLIFIED IDEIA HP STAR KIT</tradeName>
    <deviceName>AMPLIFIED IDEIA HP STAR KIT</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K663011-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:09.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026064266</udiDi>
    <basicUdiDi>357302BUDI000589UD</basicUdiDi>
    <tradeName>VIDAS® H. pylori IgG</tradeName>
    <deviceName>VIDAS® H. pylori IgG</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30192</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:47:54.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313276912</udiDi>
    <basicUdiDi>B-86060313276912</basicUdiDi>
    <tradeName>H. pylori 2nd Gen.</tradeName>
    <deviceName>H. pylori 2nd Gen.</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1807V24GHP2</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:49.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440206958</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA106L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:47:14.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440239062</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA101L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:50.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440239079</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA101H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:48.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440206965</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA106H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:42.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440206989</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA112H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:40.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440206996</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA113L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:26.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440207009</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA113H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:25.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440215233</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA196T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:24.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440239109</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:19.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440211754</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA136</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:16.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440211761</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA172</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:14.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440239086</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA101LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:09.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440239093</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA101HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:09.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440215806</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-CLA106LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:14:07.801Z</lastUpdated>
  </row>
</eudamedExport>