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274 device results listed.

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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

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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

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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

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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

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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: 08435440239062
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA101L
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

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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: 08435440239079
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA101H
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

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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: 08435440206965
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA106H
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

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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: 08435440206989
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA112H
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

Manufacturer products 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: 08435440206996
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA113L
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

Manufacturer products 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: 08435440207009
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA113H
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

Manufacturer products 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: 08435440215233
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA196T
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

Manufacturer products 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: 08435440239109
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA101
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

Manufacturer products 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: 08435440211754
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA136
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

Manufacturer products 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: 08435440211761
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA172
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

Manufacturer products 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: 08435440239086
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA101LE
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

Manufacturer products 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: 08435440239093
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA101HE
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:14

Manufacturer products View details