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192 device results listed.

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H.Pylori Antibody Rapid Test

50Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303353
Basic UDI-DI: B-06974566303353
Reference: IHP-30250
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303346
Basic UDI-DI: B-06974566303346
Reference: IHP-30225
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori (HP) Antigen Test Kit

25Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303285
Basic UDI-DI: B-06974566303285
Reference: IHP-60225
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Estonia
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori (HP) Antigen Test Kit

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303278
Basic UDI-DI: B-06974566303278
Reference: IHP-6021
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori (HP) Antigen Test Kit

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303261
Basic UDI-DI: B-06974566303261
Reference: IHP-6021
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Prueba Rápida de antígeno de H. Pylori en casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126120
Basic UDI-DI: B-06936983126120
Reference: IHP-602
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

PYLORITOP AG

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03700531700208
Basic UDI-DI: B-03700531700208
Reference: 1030011
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

PYLORITOP Ab BSS

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678590264
Basic UDI-DI: B-03532678590264
Reference: SW30001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Helicobacter pylori (HP) Antigen Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561222
Basic UDI-DI: B-00628347561222
Reference: A02-11-422
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Helicobacter Pylori (HP) Antibody Test

cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347561178
Basic UDI-DI: B-00628347561178
Reference: A02-11-222
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Fortel® Ulcer (H. pylori) Screening Test

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059100518
Basic UDI-DI: B-00083059100518
Reference: 1005-1
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Simple H.pyl-Tf

9.231.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004679
Basic UDI-DI: 84295779231XW
Reference: 9.231.020.21.000
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:18

Manufacturer products View details

Helori Urease

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169200644
Basic UDI-DI: 802816920BW01050503013Y
Reference: 1693
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 07:39

Manufacturer products View details

H.Pylori Antibody Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingSingle use

Manufacturer: Hangzhou Tongzhou Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000038774
UDI-DI: 06975156250804
Basic UDI-DI: 6975156250000DZF
Reference: I021-N4002T-25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

05902643958111

H. pylori Ag w kale - kasetki 20 szt.

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958111
Basic UDI-DI: 59026439BRT302J8
Reference: 1-302-K020
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:26

Manufacturer products View details

05902643958104

H. pylori Ab - kasetki 20 szt.

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958104
Basic UDI-DI: 59026439BRT301J6
Reference: 1-301-K020
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:26

Manufacturer products View details

Accu-Tell®H. pylori IgG Cassette (Whole Blood/Serum/Plasma)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430630
Basic UDI-DI: B-06970581430630
Reference: ABT-IDT-B13
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® H. pylori IgG/IgM/IgA Strip （Whole Blood/Serum/Plasma)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430623
Basic UDI-DI: B-06970581430623
Reference: ABT-IDT-A385
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® H. pylori IgG/IgM/IgA Cassette(Whole Blood/Serum/Plasma)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430616
Basic UDI-DI: B-06970581430616
Reference: ABT-IDT-B385
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® H. pylori Antigen Cassette (Feces)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430487
Basic UDI-DI: B-06970581430487
Reference: ABT-IDT-B76
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details