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192 device results listed.

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H. pylori Antigen Rapid Test

HP-602a-25M

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

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910635
Basic UDI-DI: 69798909110038D4
Reference: HP-602a-25M
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test

HP-402b-25M

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

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910628
Basic UDI-DI: 69798909110037D2
Reference: HP-402b-25M
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antigen Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104654
Basic UDI-DI: 6970277510000JXV
Reference: IHP-N601-25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104449
Basic UDI-DI: 6970277510000EXK
Reference: IHP-N402
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antigen Test Kit

Cassette Tube Strip

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062711643
Basic UDI-DI: 69520627J016LB
Reference: HPAg1FEST-1
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-HPAG-6.6 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080010
Basic UDI-DI: 5944759080VTHPB25SPROB6HC
Reference: VT-HPBSP-25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

Helicobacter pylori Antigen (Hp-Ag) Diagnostic Kit (Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762353
Basic UDI-DI: B-06971348762353
Reference: MF-80-25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter pylori Antigen (Hp-Ag) Diagnostic Kit (Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760946
Basic UDI-DI: B-06971348760946
Reference: MF-80-20
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

HP Ag H.pylori Antigen Rapid Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Chemtron Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018072
UDI-DI: 06977775224211
Basic UDI-DI: 693869768022RS
Reference: 8022
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Belgium
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics ASSURE H. pylori Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000740
Basic UDI-DI: B-08887581000740
Reference: 43490-020
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 18.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-A056DA

INDICAID™ Helicobacter pylori Rapid IgG Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A056DA
Basic UDI-DI: B-A056DA
Reference: INDICAID™ Helicobacter pylori Rapid IgG Antibody Test
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A055D8

INDICAID™ Helicobacter pylori Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A055D8
Basic UDI-DI: B-A055D8
Reference: INDICAID™ Helicobacter pylori Rapid Antigen Test
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir03137BT

H.Pylori Ag Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir03137BT
Basic UDI-DI: B-697994388Ir03137BT
Reference: Ir031
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir03035BJ

H.Pylori Ab Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir03035BJ
Basic UDI-DI: B-697994388Ir03035BJ
Reference: Ir030
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840303704
Basic UDI-DI: B-69743840303704
Reference: 3020501
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antigen Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840302882
Basic UDI-DI: B-69743840302882
Reference: 3020502
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antigen Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HPAG001QECU
Basic UDI-DI: B-697424646HPAG001QECU
Reference: HPAg-5011/HPAg-5012
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antigen FIA Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HPAG000FZLWM
Basic UDI-DI: B-697424646HPAG000FZLWM
Reference: HPAg -5012F
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antibodies Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HPAB001PBAJ
Basic UDI-DI: B-697424646HPAB001PBAJ
Reference: HPAb-4011/HPAb-4012
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antibodies Rapid Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HPAB002PDAT
Basic UDI-DI: B-697424646HPAB002PDAT
Reference: HPAb-3011/HPAb-3012
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details