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274 device results listed.

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06975491761164

1 test/ kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Sciarray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000038307
UDI-DI: 06975491761164
Basic UDI-DI: B-06975491761164
Reference: 1 test/ kit
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter pylori Assay kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225848
Basic UDI-DI: B-06975424225848
Reference: DL247101C
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

06975424225077

50tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225077
Basic UDI-DI: B-06975424225077
Reference: DL247102
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter pylori Assay Kit (Fluorescence Immunoassay)

20T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223196
Basic UDI-DI: B-06975424223196
Reference: 20T
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:38

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

Helicobacter Pylori（HP）Antigen 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: 06975068490374
Basic UDI-DI: B-06975068490374
Reference: CP083.B1
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

POCBio H.Pylori Antigen Rapid Test

LATG02-C25

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nexlab Co., Ltd.
Manufacturer SRN: CN-MF-000047094
UDI-DI: 06974912093860
Basic UDI-DI: B-06974912093860
Reference: LATG02-C25
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
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-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

Gastric Helicobacter pylori (HP) polypeptide antigen Test kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620599
Basic UDI-DI: B-06974854620599
Reference: P2201125
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
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

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

KEYU H. Pylori Rapid Rapid Test (Colloidal Gold)

HP-R-G

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360880
Basic UDI-DI: B-06974735360880
Reference: HP-R-G
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

HP-I

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360781
Basic UDI-DI: B-06974735360781
Reference: HP-I
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

HP-III

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360644
Basic UDI-DI: B-06974735360644
Reference: HP-III
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

HP-II

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360415
Basic UDI-DI: B-06974735360415
Reference: HP-II
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU H. Pylori Rapid Rapid Test (Colloidal Gold)

HP-R-F

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360217
Basic UDI-DI: B-06974735360217
Reference: HP-R-F
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:32

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

H. Pylori Ab FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892381
Basic UDI-DI: B-06974674892381
Reference: 18-02-0068
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:14

Manufacturer products Authorised representative products Authorised representative actors View details

H. Pylori Ag FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892374
Basic UDI-DI: B-06974674892374
Reference: 18-02-0067
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:14

Manufacturer products Authorised representative products Authorised representative actors View details