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85 device results listed.

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H. pylori Ab Rapid Test Cassette (Serum/Plasma)

GCHP-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-302aYN
Basic UDI-DI: B-GCHP-302aYN
Reference: GCHP-302a
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ab Rapid Test Strip (Serum/Plasma)

GCHP-301a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-301aYK
Basic UDI-DI: B-GCHP-301aYK
Reference: GCHP-301a
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

H. Pylori Antibody Rapid Test Kit(Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349CR008GK
Basic UDI-DI: B-CNMF000054349CR008GK
Reference: CR008
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori IgG assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7O02FA
Basic UDI-DI: B-7O02FA
Reference: 7O02V1-B-EU, 7O02U1-B-EU, 7O02P1-B-EU
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601382
Basic UDI-DI: B-16972698601382
Reference: P221103
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

HP-Ab Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763723
Basic UDI-DI: B-15065023763723
Reference: TV20034
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

H. Pylori Ab Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763129
Basic UDI-DI: B-15065023763129
Reference: TV10013
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-131H50TSC2Q
Basic UDI-DI: B-131H50TSC2Q
Reference: 131H50TSC
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 11.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori Antibody (HP) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-131H150TSCJE
Basic UDI-DI: B-131H150TSCJE
Reference: 131H150TSC
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 11.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™H.Pylori Ab Rapid Test Kit

VMD35

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941421
Basic UDI-DI: B-08683347941421
Reference: VMD35
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:04

Manufacturer products View details

06977903341124

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903341124
Basic UDI-DI: B-06977903341124
Reference: GS110501C25
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

06977903341117

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903341117
Basic UDI-DI: B-06977903341117
Reference: GS110501C01
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:31

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori (HP) Antibody Rapid Test Device(Serum/Plasma)

D121401D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753475508
Basic UDI-DI: B-06976753475508
Reference: D121401D
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Ab Rapid Test Device(Whole blood/Serum/Plasma)

D080501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753475058
Basic UDI-DI: B-06976753475058
Reference: D080501D
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori（HP）IgG Antibody Rapid Quantitative Test（Fluorescence Immunoassay）

25Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490893
Basic UDI-DI: B-06975068490893
Reference: CP084.B1
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:31

Manufacturer products Authorised representative products Authorised representative actors View details

POCBio H.Pylori Antibody Rapid Test

LATG01-C50

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093853
Basic UDI-DI: B-06974912093853
Reference: LATG01-C50
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

POCBio H.Pylori Antibody Rapid Test

LATG01-C25

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093846
Basic UDI-DI: B-06974912093846
Reference: LATG01-C25
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori (HP) Urease Antibody Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620582
Basic UDI-DI: B-06974854620582
Reference: P2201025
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750464
Basic UDI-DI: B-06974785750464
Reference: IHP-5013
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:43

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori IgG (HP IgG) Detection Kit(CLIA)

50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674893012
Basic UDI-DI: B-06974674893012
Reference: 18-02-0173
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:17

Manufacturer products Authorised representative products Authorised representative actors View details