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

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48 device results listed.

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Helicobacter pylori typingl 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: 06955792732513
Basic UDI-DI: B-06955792732513
Reference: S3205E-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 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter pylori typingl 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: 06955792732506
Basic UDI-DI: B-06955792732506
Reference: S3205E-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 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

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

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

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

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: 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

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: 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

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: 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

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: 08435440215806
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA106LE
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: 08435440215837
Basic UDI-DI: 84354402_MDXGASTROB_CLAPW
Reference: VS-CLA106HE
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