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EUDAMED Device Search

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

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21.09.2026 00:16

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98 device results listed.

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K-ASSAY H. pylori

H. pylori Test Reagent

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021136
Basic UDI-DI: B-00816426021136
Reference: KAI-240
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

GAP IgM Helicobacter pylori ELISA

7006

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059070064
Basic UDI-DI: B-00083059070064
Reference: 7006
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

CHORUS HELICOBACTER PYLORI IgA

CHORUSPYA

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

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322403
Basic UDI-DI: 803389132CHORUSPYA00C7
Reference: 81062
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

CHORUS HELICOBACTER PYLORI IgG

CHORUSPYG

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

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322397
Basic UDI-DI: 803389132CHORUSPYG00D5
Reference: 81060
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

H. pylori Antibody Rapid Test

Format (cassette): A4A411125, A4A411140, A4A411225, A4A411240 Format (strip): A4A410150, A4A410250

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804831967
Basic UDI-DI: 69528048A4A41105L
Reference: Format (cassette): A4A411;Format (strip): A4A410
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062773238
Basic UDI-DI: B-06952062773238
Reference: HPAb1W-1
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 28.06.2026 11:25

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771715
Basic UDI-DI: B-06952062771715
Reference: HPAb1W-50
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 28.06.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771708
Basic UDI-DI: B-06952062771708
Reference: HPAb1W-25
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 28.06.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771692
Basic UDI-DI: B-06952062771692
Reference: HPAb2W-50
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 28.06.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Test Kit

Cassette Strip

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062700067
Basic UDI-DI: B-06952062700067
Reference: HPAb1W-1
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 28.06.2026 11:21

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antibody Rapid Test Kit

25 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580323
Basic UDI-DI: 697518250G118073B
Reference: G11807
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori Urease Antibody (Urease Ab) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502286
Basic UDI-DI: B-06942028502286
Reference: DF1101
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Anti-H.Pylori Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155808311
Basic UDI-DI: B-06936155808311
Reference: ITP10212-DS50
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Anti-H.Pylori Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155807123
Basic UDI-DI: B-06936155807123
Reference: ITP10002-DS50
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Anti-H.Pylori Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155804641
Basic UDI-DI: B-06936155804641
Reference: ITP10212-TC40
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:13

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Anti-H.Pylori Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155803569
Basic UDI-DI: B-06936155803569
Reference: ITP10002-TC40
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:12

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04260658551842
Basic UDI-DI: B-04260658551842
Reference: 8.04.20.0.0020, 8.04.20.0.0025, 8.04.20.0.0030
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 03:34

Manufacturer products View details

-

IVD generalNot specifiedOn the market

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04260658551811
Basic UDI-DI: B-04260658551811
Reference: 8.04.21.0.0020
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 03:34

Manufacturer products View details