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319 device results listed.

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Helicobacter Pylori and Toxin (VacA/CagA) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229510
Basic UDI-DI: B-06971042229510
Reference: SD-0318-02
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antigen Test kit

Cassette Strip Tube

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771746
Basic UDI-DI: B-06952062771746
Reference: HPAg1FE-50
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

PreventID® H. pylori Antigen

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013506
Basic UDI-DI: B-04050598013506
Reference: KSTIHP602G10
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:50

Manufacturer products View details

PreventID® H. pylori

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013353
Basic UDI-DI: B-04050598013353
Reference: KST18116GP
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:50

Manufacturer products View details

IDK® Helicobacter pylori Antigen ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000292
Basic UDI-DI: B-04050598000292
Reference: K 6923
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:39

Manufacturer products View details

Fecal Helicobacter pylori-Antigen ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325008939
Basic UDI-DI: B-04049325008939
Reference: RE58891
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

Helicobacter pylori IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325002364
Basic UDI-DI: B-04049325002364
Reference: RE56391
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

Manufacturer products View details

Helicobacter pylori IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325002357
Basic UDI-DI: B-04049325002357
Reference: RE56381
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

Manufacturer products View details

Helicobacter pylori IgA ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325002340
Basic UDI-DI: B-04049325002340
Reference: RE56371
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

Manufacturer products View details

GenoType HelicoDR VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055001217
Basic UDI-DI: B-04049055001217
Reference: 337
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

K-ASSAY H. pylori Calibrator

H. pylori Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021143
Basic UDI-DI: B-00816426021143
Reference: KAI-241C
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY H. pylori

H. pylori Test Reagent

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021136
Basic UDI-DI: B-00816426021136
Reference: KAI-240
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Hp Detect™ Stool Antigen ELISA

7083

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059070835
Basic UDI-DI: B-00083059070835
Reference: 7083
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

GAP IgM Helicobacter pylori ELISA

7006

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059070064
Basic UDI-DI: B-00083059070064
Reference: 7006
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori and Toxin Nucleic Acid Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807175096R2
Basic UDI-DI: B-000012807175096R2
Reference: HWTS-OT139
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

HELICHECK

RAPID UREASE TEST FOR DETECTION OF HELICOBACTER PYLORI BY LOOKING AT UREASE ACTIVITY IN BIOPSY SAMPLES

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: Innovative Biotechnology Organization Trade Limited Company
Manufacturer SRN: TR-MF-000037634
UDI-DI: 08681677201512
Basic UDI-DI: 86816772HPJ9
Reference: HP010
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:33

Manufacturer products View details

HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST

VCM103

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290104
Basic UDI-DI: 843661029VCM10301LA
Reference: VCM103
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:57

Manufacturer products View details

Ureasi Rapid Test

TESTRAPIDQY

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Microbiol S.r.l.
Manufacturer SRN: IT-MF-000052547
UDI-DI: 08057920720817
Basic UDI-DI: 8057920RAPIDTESTQY
Reference: K.301
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:52

Manufacturer products View details

CHORUS HELICOBATER PYLORI Ag

CHORUSPAG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891326968
Basic UDI-DI: 803389132CHORUSPAG007V
Reference: 81063
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

Manufacturer products View details

CHORUS CLIA HELICOBATER PYLORI Ag

CHORUSCPAGDU

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322939
Basic UDI-DI: 803389132CHORUSCPAGDU
Reference: 82302
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

Manufacturer products View details