<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06952062711711</udiDi>
    <basicUdiDi>69520627J016LB</basicUdiDi>
    <tradeName>H.Pylori Antigen Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAg4FEST-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:18:16.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180728022NN</udiDi>
    <basicUdiDi>B-CNM0000180728022NN</basicUdiDi>
    <tradeName>D-CNM0000180728022NN</tradeName>
    <deviceName>H.pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8022C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:29.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B262VB</udiDi>
    <basicUdiDi>B-ABT-IDT-B262VB</basicUdiDi>
    <tradeName>Accu-Tell® H. pylori IgG Cassette(Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® H. pylori IgG Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B262</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:19.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A13UB</udiDi>
    <basicUdiDi>B-ABT-IDT-A13UB</basicUdiDi>
    <tradeName>Accu-Tell® H. pylori IgG Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® H. pylori IgG Strip</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-A13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:57.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-888017SY</udiDi>
    <basicUdiDi>B-888017SY</basicUdiDi>
    <tradeName>Dr. Max Helicobacter pylori test</tradeName>
    <deviceName>Dr. Max Helicobacter pylori Test</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>888017-1</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:26.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-888017-1ER</udiDi>
    <basicUdiDi>B-888017-1ER</basicUdiDi>
    <tradeName>Dr Max+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>888017-1CRS</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:25.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942150018</udiDi>
    <basicUdiDi>B-84365942150018</basicUdiDi>
    <tradeName>30 controles positivos H. pylori (sin test rápido)</tradeName>
    <deviceName>biotical H. pylori Positive control (30u)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT30PG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:11:59.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942149982</udiDi>
    <basicUdiDi>B-84365942149982</basicUdiDi>
    <tradeName>biotical H. pylori Card (+PC +NC)</tradeName>
    <deviceName>biotical H. pylori Card (+PC +NC)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25PGCN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:11:59.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942149814</udiDi>
    <basicUdiDi>B-84365942149814</basicUdiDi>
    <tradeName>biotical H. pylori Card (+PC)</tradeName>
    <deviceName>biotical H. pylori Card (+PC)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25PGC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:11:58.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>84365942149746</udiDi>
    <basicUdiDi>B-84365942149746</basicUdiDi>
    <tradeName>biotical H. pylori Card</tradeName>
    <deviceName>biotical H. pylori Card</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25PG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:11:57.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779076YAJE</udiDi>
    <basicUdiDi>B-84295779076YAJE</basicUdiDi>
    <tradeName>Simple H.pyl / Stick H.pyl</tradeName>
    <deviceName>Simple H.pyl / Stick H.pyl</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.076.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:04.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808120Q2</udiDi>
    <basicUdiDi>B-808120Q2</basicUdiDi>
    <tradeName>D-808120Q2</tradeName>
    <deviceName>H.pylori Ag Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:54:19.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808056QJ</udiDi>
    <basicUdiDi>B-808056QJ</basicUdiDi>
    <tradeName>D-808056QJ</tradeName>
    <deviceName>H.pylori Ab Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808056</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:54:05.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-801016NM</udiDi>
    <basicUdiDi>B-801016NM</basicUdiDi>
    <tradeName>TEST AUTODIAGNOSTICO HELICOBACTER PYLORI</tradeName>
    <deviceName>TEST AUTODIAGNOSTICO HELICOBACTER PYLORI</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:37.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050207VJF6</udiDi>
    <basicUdiDi>B-4680008050207VJF6</basicUdiDi>
    <tradeName>AMA RUT Pro (48 in blocks)</tradeName>
    <deviceName>Helicobacter pylori AMA RAPID UREASE TEST (AMA RUT Pro)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0207</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:49.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050206VGET</udiDi>
    <basicUdiDi>B-4680008050206VGET</basicUdiDi>
    <tradeName>AMA RUT Pro (block of 24)</tradeName>
    <deviceName>Helicobacter pylori AMA RAPID UREASE TEST (AMA RUT Pro)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0206</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:47.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050205VEEJ</udiDi>
    <basicUdiDi>B-4680008050205VEEJ</basicUdiDi>
    <tradeName>AMA RUT Expert</tradeName>
    <deviceName>Helicobacter pylori AMA RAPID UREASE TEST (AMA RUT Expert)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0205</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:45.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050109VHEZ</udiDi>
    <basicUdiDi>B-4680008050109VHEZ</basicUdiDi>
    <tradeName>HELIC ABT Reader indicator tube kit (30 pcs)</tradeName>
    <deviceName>HELIC ABT Reader indicator tube kit (30 pcs)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0109</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:43.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050107VDEF</udiDi>
    <basicUdiDi>B-4680008050107VDEF</basicUdiDi>
    <tradeName>HELIC ABT Reader indicator tube kit (1 pcs)</tradeName>
    <deviceName>HELIC ABT Reader indicator tube kit (1 pcs)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0107</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:41.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050106VBE6</udiDi>
    <basicUdiDi>B-4680008050106VBE6</basicUdiDi>
    <tradeName>HELIC ABT Reader indicator tube kit (50 pcs)</tradeName>
    <deviceName>HELIC ABT Reader indicator tube kit (50 pcs)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0106</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:38.632Z</lastUpdated>
  </row>
</eudamedExport>