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309 device results listed.

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Helicobacter pylori(HP) IgG Test Kit(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CI-HPG9K
Basic UDI-DI: B-CI-HPG9K
Reference: CI-HPG
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 20.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 H. pylori IgG

IVDR_67_LLB_DUB-C_B_KIT_H. pylori IgG

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961637
Basic UDI-DI: 0405686901386VV
Reference: 10381336
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:15

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold)

HP-Ag strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991602QG
Basic UDI-DI: B-693757991602QG
Reference: HP-Ag501601 HP-Ag251602
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody (HP) Test

HP strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991601QE
Basic UDI-DI: B-693757991601QE
Reference: HP strip cassette
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062773283
Basic UDI-DI: B-06952062773283
Reference: HPAb2W-50
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062773276
Basic UDI-DI: B-06952062773276
Reference: HPAb2W-20
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062773269
Basic UDI-DI: B-06952062773269
Reference: HPAb2W-10
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062773252
Basic UDI-DI: B-06952062773252
Reference: HPAb1W-25
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062773245
Basic UDI-DI: B-06952062773245
Reference: HPAb1W-5
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:56

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: 06952062771739
Basic UDI-DI: B-06952062771739
Reference: HPAg1FE-25
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:56

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: 06952062771722
Basic UDI-DI: B-06952062771722
Reference: HPAg2FE-50
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

04099466111425

Serazym® H. pylori 2nd Gen.

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466111425
Basic UDI-DI: B-04099466111425
Reference: E-114
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

K-ASSAY H. pylori Control

H. pylori Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021150
Basic UDI-DI: B-00816426021150
Reference: K242C-2M
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 16.07.2026 13:33

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIPHELG022DS05

NovaLisa® Helicobacter pylori IgG plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPHELG022DS05
Basic UDI-DI: B-+ENTIPHELG022DS05
Reference: PHELG022DS
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIPHELG02207

NovaLisa® Helicobacter pylori IgG plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPHELG02207
Basic UDI-DI: B-+ENTIPHELG02207
Reference: PHELG022
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTIHELM02200V

NovaLisa® Helicobacter pylori IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHELM02200V
Basic UDI-DI: B-+ENTIHELM02200V
Reference: HELM0220
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHELG0220DS0N

NovaLisa® Helicobacter pylori IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHELG0220DS0N
Basic UDI-DI: B-+ENTIHELG0220DS0N
Reference: HELG0220DS
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHELG02200P

NovaLisa® Helicobacter pylori IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHELG02200P
Basic UDI-DI: B-+ENTIHELG02200P
Reference: HELG0220
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTI302193020G

Helicobacter pylori IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI302193020G
Basic UDI-DI: B-+ENTI302193020G
Reference: 30219302
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

+ENTI301140480H

Helicobacter pylori IgG plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140480H
Basic UDI-DI: B-+ENTI301140480H
Reference: 30114048
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details