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274 device results listed.

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+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

+ENTI301140460F

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: +ENTI301140460F
Basic UDI-DI: B-+ENTI301140460F
Reference: 30114046
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

VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440206972
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA112L
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

OnSite® H. pylori Ag Rapid Test

R0192C

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

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114460986
Basic UDI-DI: 081011446R0192CEF
Reference: R0192C-50T
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antigen Test Kit

VID83-

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID83-FK
Basic UDI-DI: B-VID83-FK
Reference: VID83- 01-011
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

VID82-

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID82-FG
Basic UDI-DI: B-VID82-FG
Reference: VID82- 01-011
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-534A

Helicobacter Pylori Antibody Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-534A
Basic UDI-DI: B-TD-HNKX-CED-534A
Reference: /
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-5248

Helicobacter Pylori Antigen Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-5248
Basic UDI-DI: B-TD-HNKX-CED-5248
Reference: /
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

BGI

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022021E6
Basic UDI-DI: B-SAC2022021E6
Reference: SAC2022021
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022020E4
Basic UDI-DI: B-SAC2022020E4
Reference: SAC2022020
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022019EK
Basic UDI-DI: B-SAC2022019EK
Reference: SAC2022019
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022004E6
Basic UDI-DI: B-SAC2022004E6
Reference: SAC2022004
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

ILE-HEL036B

Helicobacter pylori IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: ILE-HEL036B
Basic UDI-DI: B-ILE-HEL036B
Reference: ILE-HEL03
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 01:10

Manufacturer products View details

ILE-HEL0269

Helicobacter pylori IgA ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: ILE-HEL0269
Basic UDI-DI: B-ILE-HEL0269
Reference: ILE-HEL02
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 01:10

Manufacturer products View details

ILE-HEL0167

Helicobacter pylori IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: ILE-HEL0167
Basic UDI-DI: B-ILE-HEL0167
Reference: ILE-HEL01
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 01:10

Manufacturer products View details

H. pylori Antibody Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHP-R402FH
Basic UDI-DI: B-IHP-R402FH
Reference: IHP-R402
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHP-R302FC
Basic UDI-DI: B-IHP-R302FC
Reference: IHP-R302
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

Hp Ab Helicobacter Pylori Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HpAb706-AEUN
Basic UDI-DI: B-HpAb706-AEUN
Reference: HpAb706-AE10Y, HpAb706-AE10N, HpAb706-AE20Y, HpAb706-AE20N
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Ab Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD153XK
Basic UDI-DI: B-GKPD153XK
Reference: GKPD153
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details