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20.09.2026 13:34

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98 device results listed.

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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

06930317871496

20 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317871496
Basic UDI-DI: B-06930317871496
Reference: DNK-2503-1
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587010403
Basic UDI-DI: B-06419587010403
Reference: 601040.02
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

Biocard™ H pylori IgG Home

3-018-200

IVD self-testing devicesIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842918030
Basic UDI-DI: B-06416842918030
Reference: 3-018-200
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

Manufacturer products View details

Biocard Helicobacter pylori IgG

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842818019
Basic UDI-DI: B-06416842818019
Reference: 3-018-110
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

Manufacturer products View details

H. Pylori

333

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100684
Basic UDI-DI: B-05404035100684
Reference: 333
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:34

Manufacturer products View details

DyonHpAb triple

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251200258
Basic UDI-DI: B-05200251200258
Reference: DNWA101
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:47

Manufacturer products View details

Laboquick

LHAB.01

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.
Manufacturer SRN: TR-MF-000032257
UDI-DI: 08699195610433
Basic UDI-DI: 86991956100LHAB.01WV
Reference: LHAB.01
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:41

Manufacturer products View details

PreventID® H. pylori

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015456
Basic UDI-DI: B-04050598015456
Reference: KST18116GP.05
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

VIDAS® H. pylori IgG

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064266
Basic UDI-DI: 357302BUDI000589UD
Reference: 30192
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:47

Manufacturer products View details

H. pylori Antibody Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHP-401SG
Basic UDI-DI: B-IHP-401SG
Reference: IHP-401
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 00:42

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-302SD
Basic UDI-DI: B-IHP-302SD
Reference: IHP-302
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IHP-402

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412615148
Basic UDI-DI: 697241261IHP-402DR
Reference: IHP-402-07
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618262
Basic UDI-DI: 697241261IHP-402DR
Reference: IHP-402-25
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details