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319 device results listed.

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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

HP-Ag Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763716
Basic UDI-DI: B-15065023763716
Reference: TV20033
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Ireland
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

Allplex™ H.pylori & ClariR Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103890
Basic UDI-DI: B-08809240103890
Reference: HC10389Z
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ H.pylori & ClariR Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102008
Basic UDI-DI: B-08809240102008
Reference: HC10200X
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ H.pylori & ClariR Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101995
Basic UDI-DI: B-08809240101995
Reference: HC10199Y
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

SOFTEC H.Pylori Antigen test

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616268
Basic UDI-DI: B-08697962616268
Reference: SFTHPAG
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

LyoSens H. pylori qPCR Kit

LYO137WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115807632
Basic UDI-DI: B-08685115807632
Reference: LYO137
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:23

Manufacturer products View details

RevoDx Helicobacter pylori qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387210874
Basic UDI-DI: B-08684387210874
Reference: IP202405-25
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 01:47

Manufacturer products View details

RevoDx Helicobacter pylori qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387210355
Basic UDI-DI: B-08684387210355
Reference: IP202405-100
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 01:46

Manufacturer products View details

OnSite® H. pylori Ag Rapid Test