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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 01:12

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108 device results listed.

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H. pylori Ag Rapid Test Strip (Feces)

GCHP-601a，GCHP-601Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-601CG
Basic UDI-DI: B-GCHP-601CG
Reference: GCHP-601a，GCHP-601Ca
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

H. Pylori Antigen Rapid Test Kit

H. Pylori Antigen Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349CR007GH
Basic UDI-DI: B-CNMF000054349CR007GH
Reference: CR007
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
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

H. pylori 2nd Gen.

H. pylori 2nd Gen.

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147176938
Basic UDI-DI: B-86060147176938
Reference: C1807V24GHP2
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

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

SOFTEC H.Pylori Antigen test

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

OnSite® H. pylori Ag Rapid Test

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114460993
Basic UDI-DI: 081011446R0192CEF
Reference: R0192C-30T
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Aria® H. pylori Ag Rapid Test

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461006
Basic UDI-DI: 081011446R0192CEF
Reference: R0192C-25T-AR
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Aria® H. pylori Ag Rapid Test

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461013
Basic UDI-DI: 081011446R0192CEF
Reference: R0192C-30T-AR
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Aria® H. pylori Ag Rapid Test

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461020
Basic UDI-DI: 081011446R0192CEF
Reference: R0192C-50T-AR
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

OnSite® H. pylori Ag Rapid Test

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461808
Basic UDI-DI: 081011446R0192CEF
Reference: R0192C-10T
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

OnSite® H. pylori Ag Rapid Test

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461815
Basic UDI-DI: 081011446R0192CEF
Reference: R0192C-20T
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Aria® H. pylori Ag Rapid Test

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461822
Basic UDI-DI: 081011446R0192CEF
Reference: R0192C-10T-AR
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Aria® H. pylori Ag Rapid Test

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461839
Basic UDI-DI: 081011446R0192CEF
Reference: R0192C-20T-AR
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 08.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter pylori Antigen Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878282020
Basic UDI-DI: B-06979878282020
Reference: 1001058
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

40 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416165
Basic UDI-DI: B-06978896416165
Reference: W-IF2-Hp-Ag-40
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416158
Basic UDI-DI: B-06978896416158
Reference: W-IF2-Hp-Ag-20
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

GP1000

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: SHENZHEN FREECOM TECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000047241
UDI-DI: 06978488900003
Basic UDI-DI: B-06978488900003
Reference: GP1000
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:44

Manufacturer products Authorised representative products Authorised representative actors View details

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903341025
Basic UDI-DI: B-06977903341025
Reference: GS110503C25
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
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

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.
Manufacturer SRN: CN-MF-000044463
UDI-DI: 06977903341018
Basic UDI-DI: B-06977903341018
Reference: GS110503C01
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
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

FOB/TRF/HP Rapid Test Cassette(Colloidal Gold

1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698402062
Basic UDI-DI: B-06977698402062
Reference: GKPD038
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details