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309 device results listed.

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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

06977454210016

Helicobacter Pylori Staining Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Guangzhou Hearty Expression Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000036085
UDI-DI: 06977454210016
Basic UDI-DI: 697745421HP01MD
Reference: EN ISO 14971
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Austria
Authorised representative: Everbiz GmbH
Last updated: 02.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

06977454210023

Helicobacter Pylori Staining Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Guangzhou Hearty Expression Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000036085
UDI-DI: 06977454210023
Basic UDI-DI: 697745421HP4P
Reference: EN ISO 14971
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Germany
Authorised representative: Everbiz GmbH
Last updated: 02.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori Test Kit (Urease)

IVD Class BNot specifiedNot intended for EU marketSingle use

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 16972235840045
Basic UDI-DI: 697223584HPTSW
Reference: LTH01-2
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

04049095161742

RIDA®Prime H. pylori BDM

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095161742
Basic UDI-DI: 4049095PM23050000JU
Reference: PM2305
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

04049095140556

RIDA®QUICK Helicobacter

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095140556
Basic UDI-DI: 4049095N230300000UR
Reference: N2303
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:50

Manufacturer products View details

04049095030253

RIDASCREEN® Helicobacter

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030253
Basic UDI-DI: 4049095C230200000JD
Reference: CRP2304
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:50

Manufacturer products View details

CHORUS HELICOBACTER PYLORI IgA

CHORUSPYA

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322403
Basic UDI-DI: 803389132CHORUSPYA00C7
Reference: 81062
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

CHORUS HELICOBACTER PYLORI IgG

CHORUSPYG

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322397
Basic UDI-DI: 803389132CHORUSPYG00D5
Reference: 81060
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

06970895477048

Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895477048
Basic UDI-DI: B-06970895477048
Reference: B052T010B0C2
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 30.06.2026 09:57

Manufacturer products Authorised representative products Authorised representative actors View details

06970895476034

H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895476034
Basic UDI-DI: B-06970895476034
Reference: B058T050B0C2
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 09:56

Manufacturer products Authorised representative products Authorised representative actors View details