Infectious diseasesInfectious immunology - rapid tests & point of careBacteriology - RT & POC

H. pylori - RT & POC

EMDN code W0105090102

77 manufacturers, 260 models including 258 on the market, 20 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 77

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Family Health Self Test Helicobacter Pylori IHP-N602H-013 refs Gesunder Magen2 refs98/79 H. pylori Antibody Rapid Test Cassette (Serum /Plasma) IHP-30298/79 H. pylori Antibody Rapid Test Cassette IHP-40298/79 H. pylori Antibody Rapid Test Cassette IHP-R40298/79 20 others H. pylori Antibody Rapid Test IHP-N4023 refs H. pylori Antigen Rapid Test (Feces) IHP-60798/79 H. pylori Antigen Rapid Test Cassette (Feces) IHP-60298/79 H. pylori Antigen Rapid Test Cassette IHP-602H98/79 H. pylori Antigen Rapid Test Cassette(Feces) IHP-602H98/79 H. pylori Antigen Rapid Test IHP-602H98/79 H. pylori Antigen Rapid Test IHP-N601-253 refs H.pylori Antibody Rapid Test IHP-40298/79 H.pylori Antibody Rapid Test IHP-N402B98/79 H.pylori Antibody Rapid Test IHP-N402J98/79 H.pylori Antigen Rapid Test Cassette IHP-60298/79 H.pylori Antigen Rapid Test IHP-60198/79 H.pylori Antigen Rapid Test IHP-60298/79 Magsår H. Pylori98/79 Mivolis H. pylori Antigen Rapid Test Cassette98/79 Mivolis Schnelltest Gesunder Magen2 refs98/79 Prueba Rápida de antígeno de H. Pylori en casete98/79 Schnelltest Gesunder Magen98/79 Szybki test kasetkowy do wykrywania Helicobacter pylori w kale98/79 ZuhauseTEST Gesunder Magen2 refs98/79	B, C IVDR, 98/79	info@alltests.com.cn EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	H.Pylori Ab Test IHP0198/79 H.Pylori Ab Test IHP0298/79 H.Pylori Ab Test RTHP0198/79 H.Pylori Ab Test RTHP0298/79 H.Pylori Ab Test THP0198/79 10 others H.Pylori Ab Test THP0298/79 H.Pylori Ab Test TIHP0298/79 H.Pylori Ab Test TIHP0200198/79 H.Pylori Ab Test TIHP0201098/79 H.Pylori Ag Test IHP0398/79 H.Pylori Ag Test RTHP0398/79 H.Pylori Ag Test THP0398/79 H.Pylori Ag Test TIHP0398/79 H.Pylori Ag Test TIHP0300198/79 H.Pylori Ag Test TIHP0301098/79	– 98/79	Website info@turklab.com.tr EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	H. pylori Antigen Assay Kit (Colloidal Gold) 1 test/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 10 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 100 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 25 tests/kit98/79 H. pylori Antigen Assay Kit (Colloidal Gold) 5 tests/kit98/79 6 others H. pylori Antigen Assay Kit (Colloidal Gold) 50 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 20 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 H. pylori Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : CEpartner4U (Netherlands)	China	Exacto-85879598/79 R102-11098/79 R102-11298/79 R102-11498/79 R108-11098/79 5 others R108-11298/79 R109-11298/79 R18-11098/79 R18-11298/79 R18-11698/79	– 98/79	EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	H. pylori Ab Rapid Test Cassette (Serum/Plasma) GCHP-302a98/79 H. pylori Ab Rapid Test Cassette (Whole blood/Serum/Plasma) GCHP-402a98/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602a98/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602Ca98/79 H. pylori Ag Rapid Test Strip (Feces) GCHP-601a98/79 4 others H. pylori Ag Rapid Test Strip (Feces) GCHP-601Ca98/79 H.pylori Ag Rapid Test Device (Feces) GCHP-606a98/79 H. pylori Ab Rapid Test Strip (Serum/Plasma) GCHP-301a98/79 H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma) GCHP-401a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany)	China	Accu-Tell® H. pylori Antigen Cassette (Feces)98/79 Accu-Tell® H. pylori IgG Cassette(Serum/Plasma)98/79 Accu-Tell® H. pylori IgG Strip (Whole Blood/Serum/Plasma)98/79 Accu-Tell® H. pylori IgG/IgM/IgA Cassette(Whole Blood/Serum/Plasma)98/79 Accu-Tell® H. pylori IgG/IgM/IgA Strip （Whole Blood/Serum/Plasma)98/79 1 other Accu-Tell®H. pylori IgG Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	sales@accubiotech.com EUDAMED record Report an error
Association Of Medicine Analytics EU representative : CMC Medical Devices & Drugs SL (Spain)	Russia	AMA RUT Expert98/79 AMA RUT Pro (48 in blocks)98/79 AMA RUT Pro (block of 24)98/79 HELIC ABT Reader indicator tube kit (1 pcs)98/79 HELIC ABT Reader indicator tube kit (30 pcs)98/79 1 other HELIC ABT Reader indicator tube kit (50 pcs)98/79	– 98/79	Website EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain)	China	1 test/kit98/79 10 tests/kit98/79 100 tests/kit98/79 20 tests/kit98/79 5 tests/kit98/79 1 other 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Safecare FDA EU representative : UnicareQ GmbH (Germany) and 1 other	China	"H.pylori Antibodies Rapid Test Kit (Whole Blood/serum/plasma)" HPAb-4011/HPAb-401298/79 H.pylori Antibodies Rapid Test (Serum/Plasma) HPAb-3011/HPAb-301298/79 H.pylori Antibodies Rapid Test (Whole Blood/Serum/Plasma) HPAb-4011/HPAb-401298/79 H.pylori Antigen FIA Test (Feces)98/79 H.pylori Antigen Rapid Test (Feces) HPAg-5011/HPAg-501298/79 1 other H.pylori Antigen Rapid Test Kit(Feces) HPAg-5011/HPAg-501298/79	– 98/79	EUDAMED record Report an error
Vitrosens	Türkiye	RapidFor™5 refs RapidFor™ H.pylori Ag Rapid Test Kit (FIA) VMPO6798/79 RapidFor™ H.Pylori v2.0 Test Kit RapidFor™ VMD16TD98/79 RapidFor™ VMD16TD0198/79 1 other RapidFor™ VMPO67GD98/79	B, C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Avioq Bio-tech EU representative : SUNGO Europe B.V. (Netherlands)	China	1 Test/Kit98/79 2 Tests/Kit98/79 20 Tests/Kit98/79 40 Tests/Kit98/79 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain)	Canada	H. pylori Antibody Rapid Test Cassette IHP-302(CT)98/79 H.pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) IHP-40298/79 H.pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) IHP-402(CT)98/79 H.pylori Antigen Rapid Test Cassette (Feces) IHP-60298/79 H.pylori Antigen Rapid Test Cassette (Feces) IHP-602(CT)98/79	– 98/79	ra02@citestdiagnostics.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	H.Pylori Antibody Rapid Test 25Tests/Kit98/79 H.Pylori Antibody Rapid Test 50Tests/Kit98/79 Helicobacter Pylori (HP) Antigen Test Kit 1Test/Kit98/79 Helicobacter Pylori (HP) Antigen Test Kit 20Tests/Kit98/79 Helicobacter Pylori (HP) Antigen Test Kit 25Test/Kit98/79	– 98/79	Website EUDAMED record Report an error
Vivachek FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	H. pylori Ab Rapid Test VIHP2 refs98/79 H. pylori Ag Rapid Test VIHP98/79 H. pylori Ag Rapid Test VIHP-40198/79 H. pylori Antibody Test Kit (FIA) VID8298/79 H. pylori Antigen Test Kit ( FIA) VID8398/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium)	China	Diagnostic Kit for Antibody Subtype to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antibody to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antibody to Helicobacter Pylori(Colloidal Gold)98/79 Diagnostic Kit for Antigen to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)98/79 Diagnostic Kit for Antigen to Helicobacter Pylori (Latex)98/79	– 98/79	EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Bioline™ H.pylori 04FK1098/79 Bioline™ H.pylori 04FK1198/79 SD BIOLINE H.pylori 04FK1098/79 SD BIOLINE H.pylori 04FK1198/79	– 98/79	Website EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	H. pylori Antibodies Rapid Test HP-P11, HP-P23, HP-W11, HP-W2398/79 H. pylori Antibodies Rapid Test HP-W2398/79 H. pylori Antibody FIA HP-W23F398/79 H. pylori Antigen FIA HP-F23F398/79	– 98/79	Website contact@diareagent.com EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	Helicobacter Pylori Antibody Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Helicobacter Pylori Antibody Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Helicobacter pylori antigen Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Helicobacter pylori antigen Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
Biotical	Spain	biotical H. pylori Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo H. pylori +1 C. Negativo universal)98/79 biotical H. pylori Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo H. pylori)98/79 biotical H. pylori Card / 25 test rápidos con viales para muestra fecal (sin controles externos).98/79 biotical H. pylori Positive control (30u) / 30 controles positivos H. pylori (sin test rápido)98/79	– 98/79	Website EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany)	China	H. pylori Antigen Rapid Test HP-602a98/79 H. pylori Antibody Rapid Test HP-402b98/79 Medotex H. pylori Antigen Rapid Test HP-602a Medotex H. pylori Antibody Rapid Test HP-402b	B IVDR, 98/79	Website EUDAMED record Report an error
nal von minden	Germany	NADAL® H.pylori Ag Test2 refs98/79 NADAL® H.pylori Ab Test2 refs98/79 S-MedPro H.pylori Ab Test98/79 S-MedPro H.pylori Ag Test98/79	– 98/79	Website info@nal-vonminden.com EUDAMED record Report an error
Nanjing Leading Medical Technology EU representative : Medunion S.L. (Spain)	China	1 Test/Bag98/79 1 Test/Box98/79 25 Tests/Box98/79 50 Tests/Box98/79	– 98/79	EUDAMED record Report an error
Singclean EU representative : SUNGO Europe B.V. (Netherlands)	China	Singclean Cassette：1 test/box98/79 Singclean Cassette：10 tests/box98/79 Singclean Cassette：20 tests/box98/79 Singclean Cassette：5 tests/box98/79	– 98/79	Website EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	H. pylori Ab Rapid Test Cassette (Serum, Plasma and Whole Blood)98/79 H. pylori Ab Test98/79 H. pylori Ag Rapid Test Cassette (Fecal Specimen)98/79 H. pylori Ag Test98/79	– 98/79	Website EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands)	China	H. pylori Ab Rapid Test GIHPb98/79 H. pylori Ab Test GIHPb98/79 H. pylori Ag Rapid Test GIHPg98/79 H. pylori Ag Test GIHPg98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	IHP-30298/79 IHP-40298/79 IHP-60298/79	– 98/79	EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands)	China	Rapid H.Pylori Antibody Test Card 1O02C298/79 Rapid H.Pylori Antigen Test Card (3mm) 1O03C4298/79 Rapid H.Pylori Antigen Test Card 1O03C498/79	– 98/79	Website EUDAMED record Report an error
Dyonmed	Greece	DyonHpsA98/79 Pylori test (1 test/box)98/79 Pylori test (10 tests/box)98/79	– 98/79	Website customerservice@dyonmedical.com EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	RightSign Rightsign IHPB-S4198/79 Rightsign IHPC-MC3298/79	B IVDR, 98/79	info@biotests.com.cn EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	H. pylori Ab Rapid Test Cassette (Serum/Plasma) GCHP-302a98/79 H. pylori Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHP-402a98/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602a98/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti	Türkiye	CERTAIN98/79 LABOQUICK98/79 SURELAB98/79	– 98/79	Website info@koroglugroup.com EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany)	Germany, Singapore	MP Diagnostics ASSURE H. pylori Antigen Rapid Test98/79 MP Diagnostics ASSURE H. pylori Rapid Test98/79 Rapid H.pylori Antigen Test Card98/79	– 98/79	Website EUDAMED record Report an error
PRIMA Lab EU representative : QbD RepS BV (Belgium)	Switzerland	Autotest Helicobacter pylori98/79 Dr. Max Helicobacter pylori test 800017-x98/79 TEST AUTODIAGNOSTICO HELICOBACTER PYLORI98/79	– 98/79	quality@primahometest.com EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	Flowflex3 refs98/79 Quik-Check3 refs98/79	– 98/79	Website EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain)	China	H. Pylori Antibody Rapid Test HP-D02a, HP-D01a98/79 H. Pylori Antigen Rapid Test HP-F02a98/79	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Artronlab FDA EU representative : MedNet EC-REP GmbH (Germany)	Canada	Artron Helicobacter Pylori (HP) Antibody Test cassette98/79 Artron Helicobacter pylori (HP) Antigen Test Cassette98/79	– 98/79	Website info@artronlab.com EUDAMED record Report an error
Atlas Medical FDA	Germany	Atlas H.pylori Antigen Test Cassette, Stool Sample, Individually Pouched, 20 Tests/Box (Buffer to be supplied in Extraction Tubes) 8.04.23.1.002098/79 Atlas H.pylori Antigen Test Strip, 3.5mm, Stool Sample, Individually Pouched, 25 Test/Box (Buffer to be supplied in Extraction Tubes) 8.04.24.1.002598/79	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
Biohit FDA	Finland	BIOHIT 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 UFT3004 refs98/79 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 quick test98/79	– 98/79	Website info@biohit.fi EUDAMED record Report an error
Biomaxima	Poland	H. pylori Ab - kasetki 20 szt. H. pylori Ag w kale - kasetki 20 szt.	B, C IVDR	Website info@biomaxima.com EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France)	Switzerland	PYLORITOP Ab BSS98/79 PYLORITOP AG98/79	– 98/79	Website reglementaire@biosynex.com EUDAMED record Report an error
Cesna	Türkiye	H.PYLORI AB HIZLI TESTİ H.PYLORI AG HIZLI TESTİ	B IVDR	Website info@cesna.com.tr EUDAMED record Report an error
Chemtronbio EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Cassette 8022C98/79 HP Ag H.pylori Antigen Rapid Test	B IVDR, 98/79	Website EUDAMED record Report an error
Clongene FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	H.pylori Antibody Rapid Tests IHPB4001, IHPB400298/79 H.pylori Antigen Rapid Test Cassette (Feces) IrHPG600298/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
Dutch Diagnostics	Netherlands	H.Pylori Ab Test2 refs98/79 H.Pylori Ag Test98/79	– 98/79	Website info@dutch-diagnostics.com EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany)	Egypt	H. pylori Ab Test 1180 00198/79 H. pylori Ag Test 1184 00198/79	– 98/79	Website info@spectrum-diagnostics.com EUDAMED record Report an error
Eurospital FDA	Italy	Helori FAST98/79 Helori Urease	B IVDR, 98/79	regulatory@eurospital.it EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	H. pylori (HP) Ag Rapid Test P202098/79 H.pylori Ab (HP Ab) Rapid Test P202198/79	– 98/79	Website info@gensurebio.com EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	H. pylori Antibody Rapid Test Cassette/Strip HIHP-402/HIHP-40198/79 H. pylori Antigen Rapid Test Cassette HIHPG-60298/79	– 98/79	EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany)	Egypt	H. pylori Ab Rapid Test Cassette (Serum, Plasma and Whole Blood) D-793 00198/79 H. pylori Ag Rapid Test Cassette (Fecal Specimen)98/79	– 98/79	EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	H.Pylori Ab Test Kit Ir03098/79 H.Pylori Ag Test Kit Ir03198/79	– 98/79	EUDAMED record Report an error
Konsung FDA EU representative : Lotus NL B.V. (Netherlands)	China	Helicobacter pylori Antibody (IgG) Test Kit (Colloidal Gold)98/79 Helicobacter pylori Antigen Test kit (Colloidal Gold)2 refs98/79	– 98/79	info@konsung.com EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany)	China	H. Pylori Antibody Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 H. Pylori Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	Website info@labnovation.com EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	H.Pylori Antibody (H.p Ab) Diagnostic Kit (Immunochromatographic Assay)2 refs98/79 Helicobacter pylori Antigen (Hp-Ag) Diagnostic Kit (Immunochromatographic Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Nano Diagnosis for Health Biotech (Guangzhou) EU representative : MedPath GmbH (Germany)	China	H.Pylori Antibody Rapid Test HPAB-0298/79 H.Pylori Antigen Rapid Test HPAG-01、HPAG-0298/79	– 98/79	EUDAMED record Report an error
Operon FDA	Spain	Simple H.pyl / Stick H.pyl 9.076.XXX.YY.ZZZ98/79 VIRAPID® HELICOBACTER PYLORI/TRANSFERRIN Ag 9.231.XXX.YY.ZZZ3 refs	B IVDR, 98/79	Website infoeudamed@operon.es EUDAMED record Report an error
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Hong Kong SAR China	INDICAID™ Helicobacter pylori Rapid Antigen Test98/79 INDICAID™ Helicobacter pylori Rapid IgG Antibody Test98/79	– 98/79	Website info@phasesci.com EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	1T/Kit2 refs98/79 20T/Kit2 refs98/79	– 98/79	info@huiantech.com EUDAMED record Report an error
Shenzhen Kang Sheng Bao Bio-Technology EU representative : QbD RepS BV (Belgium)	China	H.pylori Ab Rapid Test98/79 H.pylori Ag Rapid Test98/79	– 98/79	Website info@ksbbiotech.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	H.PYLORI AB RAPID TEST VISD013 H.PYLORI AG RAPID TEST VISD012	B IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Acmexbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Acmex Cassette98/79	– 98/79	info@acmexbio.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Mega Eurostar Sp. z o.o. (Poland)	China	H.Pylori Antigen Test Kit Cassette Tube Strip HPAg1FEST-13 refs	C IVDR	sales@dbluemedical.com EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	H. pylori Antigen Rapid Test (Feces) IHP-301398/79	– 98/79	Website EUDAMED record Report an error
Bioeuropegmbh	Germany	Fortel Ulcer (H. pylori) Screening Test 1005-198/79	– 98/79	Website info@bioeuropegmbh.com EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruVue98/79	– 98/79	EUDAMED record Report an error
Campmedica	Romania	See Now98/79	– 98/79	Website EUDAMED record Report an error
Certest	Spain	CerTest H. pylori3 refs	B IVDR	Website quality@certest.es EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany)	China	H.Pylori Ag Rapid Test Kit GKPD12998/79	– 98/79	office@guoke-medical.com EUDAMED record Report an error
Fortress Diagnostics	Northern Ireland	H.Pylori Device (WB/S/P) HPYC004098/79	– 98/79	Website info@fortressdiagnostics.com EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	H. pylori Fast Test Kit (Immunofluorescence Assay)98/79	– 98/79	EUDAMED record Report an error
Lifotronic FDA EU representative : Umedwings Netherlands B.V. (Netherlands)	China	H.Pylori Ag Test (GICA) 25 Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	LYSUN HP-F21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Monlab	Spain	H. pylori Ag MonlabTest MO-804001 25 tests98/79	– 98/79	Website EUDAMED record Report an error
Preox	Germany	preOx - HUT Helicobacter Urease Test7 refs98/79	– 98/79	Website sales@preox.de EUDAMED record Report an error
Sejoy FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	H.pylori Antibody Rapid Test Cassette98/79	– 98/79	Website EUDAMED record Report an error
Tongzhoubio FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	H.Pylori Antibody Rapid Test I021-N4002-253 refs	B IVDR	EUDAMED record Report an error
Vitro FDA	Romania	HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA) VT-HPBSP-25	B IVDR	Website office@vitro.ro EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	H. pylori Antibody Rapid Test98/79 (no longer marketed) H.pylori Antigen Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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