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224 device results listed.

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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

H.pylori Antigen Rapid Test Cassette (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277511049
Basic UDI-DI: B-06970277511049
Reference: IHP-602
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702378
Basic UDI-DI: B-06954414702378
Reference: /
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

06952999408838

IHP-602

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999408838
Basic UDI-DI: B-06952999408838
Reference: IHP-602
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

06952999408821

IHP-602

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999408821
Basic UDI-DI: B-06952999408821
Reference: IHP-602
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

06952999404342

IHP-302

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999404342
Basic UDI-DI: B-06952999404342
Reference: IHP-302
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Estonia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibodies Rapid Test

HP-W23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819354
Basic UDI-DI: B-06952804819354
Reference: HP-W23
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibodies Rapid Test

HP-P11, HP-P23, HP-W11, HP-W23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804816681
Basic UDI-DI: B-06952804816681
Reference: HP-P11 HP-P23 HP-W11 HP-W23
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody FIA

HP-W23F3

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803841
Basic UDI-DI: B-06952804803841
Reference: HP-W23F3
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details