<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCHP-302aYN</udiDi>
    <basicUdiDi>B-GCHP-302aYN</basicUdiDi>
    <tradeName>H. pylori Ab Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>H. pylori Ab Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHP-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:27:44.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHP-301aYK</udiDi>
    <basicUdiDi>B-GCHP-301aYK</basicUdiDi>
    <tradeName>H. pylori Ab Rapid Test Strip (Serum/Plasma)</tradeName>
    <deviceName>H. pylori Ab Rapid Test Strip (Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHP-301a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:27:42.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR008GK</udiDi>
    <basicUdiDi>B-CNMF000054349CR008GK</basicUdiDi>
    <tradeName>H. Pylori Antibody Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName>H. Pylori Antibody Rapid Test Kit(Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:32.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7O02FA</udiDi>
    <basicUdiDi>B-7O02FA</basicUdiDi>
    <tradeName>Helicobacter Pylori IgG assay (CLIA)</tradeName>
    <deviceName>Helicobacter Pylori IgG 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>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7O02V1-B-EU, 7O02U1-B-EU, 7O02P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:11.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601382</udiDi>
    <basicUdiDi>B-16972698601382</basicUdiDi>
    <tradeName>H. pylori Antibody Rapid Test</tradeName>
    <deviceName>H. pylori Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221103</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:19.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763723</udiDi>
    <basicUdiDi>B-15065023763723</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>HP-Ab Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20034</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:36:17.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763129</udiDi>
    <basicUdiDi>B-15065023763129</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>H. Pylori Ab Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10013</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:13.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-131H50TSC2Q</udiDi>
    <basicUdiDi>B-131H50TSC2Q</basicUdiDi>
    <tradeName>Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>131H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:58:03.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-131H150TSCJE</udiDi>
    <basicUdiDi>B-131H150TSCJE</basicUdiDi>
    <tradeName>Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>131H150TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:58:03.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683347941421</udiDi>
    <basicUdiDi>B-08683347941421</basicUdiDi>
    <tradeName>RapidFor™H.Pylori Ab Rapid Test Kit</tradeName>
    <deviceName>H.Pylori Ab Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>VMD35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:04:33.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903341124</udiDi>
    <basicUdiDi>B-06977903341124</basicUdiDi>
    <tradeName>06977903341124</tradeName>
    <deviceName>Anti-H. Pylori Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110501C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:27.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903341117</udiDi>
    <basicUdiDi>B-06977903341117</basicUdiDi>
    <tradeName>06977903341117</tradeName>
    <deviceName>Anti-H. Pylori Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110501C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:27.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753475508</udiDi>
    <basicUdiDi>B-06976753475508</basicUdiDi>
    <tradeName>H. pylori (HP) Antibody Rapid Test Device(Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D121401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:12.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753475058</udiDi>
    <basicUdiDi>B-06976753475058</basicUdiDi>
    <tradeName>H.Pylori Ab Rapid Test Device(Whole blood/Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D080501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:35.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068490893</udiDi>
    <basicUdiDi>B-06975068490893</basicUdiDi>
    <tradeName>Helicobacter Pylori（HP）IgG Antibody Rapid Quantitative Test（Fluorescence Immunoassay）</tradeName>
    <deviceName>Helicobacter Pylori（HP）IgG Antibody Rapid Quantitative Test（Fluorescence Immunoassay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP084.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:31:59.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974912093853</udiDi>
    <basicUdiDi>B-06974912093853</basicUdiDi>
    <tradeName>POCBio H.Pylori Antibody Rapid Test</tradeName>
    <deviceName>POCBio H.Pylori Antibody Rapid Test</deviceName>
    <manufacturerName>Nexlab Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047094</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LATG01-C50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:02:24.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974912093846</udiDi>
    <basicUdiDi>B-06974912093846</basicUdiDi>
    <tradeName>POCBio H.Pylori Antibody Rapid Test</tradeName>
    <deviceName>POCBio H.Pylori Antibody Rapid Test</deviceName>
    <manufacturerName>Nexlab Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047094</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LATG01-C25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:02:21.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854620582</udiDi>
    <basicUdiDi>B-06974854620582</basicUdiDi>
    <tradeName>Helicobacter Pylori (HP) Urease Antibody Detection Kit</tradeName>
    <deviceName>Helicobacter Pylori (HP) Urease Antibody Detection Kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2201025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:54.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974785750464</udiDi>
    <basicUdiDi>B-06974785750464</basicUdiDi>
    <tradeName>H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-5013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:43:17.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893012</udiDi>
    <basicUdiDi>B-06974674893012</basicUdiDi>
    <tradeName>Helicobacter Pylori IgG (HP IgG) Detection Kit(CLIA)</tradeName>
    <deviceName>Helicobacter Pylori IgG (HP IgG) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0173</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:17:58.349Z</lastUpdated>
  </row>
</eudamedExport>