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06955792732117

Helicobacter pylori universal Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732117
Basic UDI-DI: B-06955792732117
Reference: S3204E-48
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732100

Helicobacter pylori universal Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732100
Basic UDI-DI: B-06955792732100
Reference: S3204E-24
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

06930317891203

20 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317891203
Basic UDI-DI: B-06930317891203
Reference: DNK-2502-1
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

06930317871496

20 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317871496
Basic UDI-DI: B-06930317871496
Reference: DNK-2503-1
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587010403
Basic UDI-DI: B-06419587010403
Reference: 601040.02
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details

Biocard™ H pylori IgG Home

3-018-200

IVD self-testing devicesIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842918030
Basic UDI-DI: B-06416842918030
Reference: 3-018-200
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

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Biocard Helicobacter pylori IgG

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSelf testingSingle useSterile

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842818019
Basic UDI-DI: B-06416842818019
Reference: 3-018-110
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

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Biocard™ Helicobacter pylori Urease

Biocard Helicobacter pylori Urease test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06416842618015
Basic UDI-DI: B-06416842618015
Reference: 3-018-945
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:47

Manufacturer products View details

See Now

See Now Helicobacter pylori antigen

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012332
Basic UDI-DI: B-05944759012332
Reference: SN 2.2'
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Romania
Authorised representative: -
Last updated: 03.08.2026 01:44

Manufacturer products View details

H. Pylori

333

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100684
Basic UDI-DI: B-05404035100684
Reference: 333
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:34

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DyonHpAb triple

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251200258
Basic UDI-DI: B-05200251200258
Reference: DNWA101
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:47

Manufacturer products View details

05061059980403

ZENA MAX H. pylori Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980403
Basic UDI-DI: B-05061059980403
Reference: KD347533-100
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Laboquick

LHAB.01

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.
Manufacturer SRN: TR-MF-000032257
UDI-DI: 08699195610433
Basic UDI-DI: 86991956100LHAB.01WV
Reference: LHAB.01
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:41

Manufacturer products View details

TEST RAPID H. PYLORI ANTIGEN CASETA(SCAUN)

HELICOBACTER PYLORI AG RAPID TEST CASSETTE (FECES)

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080003
Basic UDI-DI: 5944759080VTHPG25STO1B6H5
Reference: VT-HPG-25
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

PreventID® H. pylori

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015456
Basic UDI-DI: B-04050598015456
Reference: KST18116GP.05
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

RAPID HP STAR LATERAL FLOW KIT

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384171736
Basic UDI-DI: 5032384RapIDHpStARE3
Reference: K671411-2
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

AMPLIFIED IDEIA HP STAR KIT

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384171811
Basic UDI-DI: 5032384IdeiaHpStarZ6
Reference: K663011-2
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® H. pylori IgG

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064266
Basic UDI-DI: 357302BUDI000589UD
Reference: 30192
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:47

Manufacturer products View details

H. pylori 2nd Gen.

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313276912
Basic UDI-DI: B-86060313276912
Reference: C1807V24GHP2
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 30.07.2026 02:29

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440206958
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA106L
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 09:47

Manufacturer products View details