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309 device results listed.

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SeraSpot® Anti-Helicobacter-6 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466300751
Basic UDI-DI: B-04099466300751
Reference: SP-007-6 G-S12
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

Manufacturer products View details

SeraSpot® Anti-Helicobacter-6 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466300744
Basic UDI-DI: B-04099466300744
Reference: SP-007-6 G-S6
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:20

Manufacturer products View details

SeraSpot® Anti-Helicobacter-6 IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466300720
Basic UDI-DI: B-04099466300720
Reference: SP-007-6 A-S12
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:20

Manufacturer products View details

SeraSpot® Anti-Helicobacter-6 IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466300713
Basic UDI-DI: B-04099466300713
Reference: SP-007-6 A-S6
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:20

Manufacturer products View details

AMPLIFIED IDEIA HP STAR KIT

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

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384171811
Basic UDI-DI: 5032384IdeiaHpStarZ6
Reference: K663011-2
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 22.09.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens™

LYO144WS96

IVD Class CIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115807519
Basic UDI-DI: 868511580PCR144GP
Reference: LYO144WS96
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 05:11

Manufacturer products View details

RapidFor™

VMD35

IVD Class CIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941421
Basic UDI-DI: 868459503VMD35DTN
Reference: VMD35D
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 02:26

Manufacturer products View details

HelicoSign Dry

HPYD050

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076700451
Basic UDI-DI: B-08800076700451
Reference: HPYD050
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 12.08.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

H.pylori Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858199
Basic UDI-DI: B-06933289858199
Reference: W493P0004
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:20

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

H.pylori Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858182
Basic UDI-DI: B-06933289858182
Reference: W493P0003
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:20

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

H.pylori Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858175
Basic UDI-DI: B-06933289858175
Reference: W493P0002
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:20

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

H.pylori Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858168
Basic UDI-DI: B-06933289858168
Reference: W493P0001
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:20

Manufacturer products Authorised representative products Authorised representative actors View details

10743816001164

Status H. pylori

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816001164
Basic UDI-DI: B-10743816001164
Reference: 37030
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

10743816001133

BioSign H. pylori

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816001133
Basic UDI-DI: B-10743816001133
Reference: BSP-406WB-35
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

HELICOBACTER PYLORI ELISA IgG

G1022

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320204
Basic UDI-DI: B-08436040320204
Reference: G1022
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

06955792735446

Helicobacter pylori Clarithromycin resistant Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)