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

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436 device results listed.

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VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217404
Basic UDI-DI: 84354402_MDXRESP_HSMYH
Reference: VS-HSM112HE
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:54

Manufacturer products View details

VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217411
Basic UDI-DI: 84354402_MDXRESP_HSMYH
Reference: VS-HSM113LE
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:54

Manufacturer products View details

VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217428
Basic UDI-DI: 84354402_MDXRESP_HSMYH
Reference: VS-HSM113HE
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:54

Manufacturer products View details

VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217442
Basic UDI-DI: 84354402_MDXRESP_HSMYH
Reference: VS-HSM196TE
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:54

Manufacturer products View details

VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217480
Basic UDI-DI: 84354402_MDXRESP_HSMYH
Reference: VS-HSM101E
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:54

Manufacturer products View details

VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217497
Basic UDI-DI: 84354402_MDXRESP_HSMYH
Reference: VS-HSM136E
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:54

Manufacturer products View details

VIASURE H. influenzae, S. pneumoniae & M. catarrhalis Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440217503
Basic UDI-DI: 84354402_MDXRESP_HSMYH
Reference: VS-HSM172E
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 22:54

Manufacturer products View details

Atypical CAP Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115804921
Basic UDI-DI: 868511580PCR129GT
Reference: LYO129WS24
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 22:45

Manufacturer products View details

Allplex™ RV Master Assay

Allplex™ RV Master Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102084
Basic UDI-DI: B-08809240102084
Reference: RV10363Z
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 13:37

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ RV Master Assay

Allplex™ RV Master Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101582
Basic UDI-DI: B-08809240101582
Reference: RV10307X
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 13:37

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115804969
Basic UDI-DI: 868511580PCR129GT
Reference: LYO129WS48
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:53

Manufacturer products View details

LYO129WS96

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805003
Basic UDI-DI: 868511580PCR129GT
Reference: LYO129WS96
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 03.08.2026 22:53

Manufacturer products View details

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IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525987
Basic UDI-DI: 868511580PCR129GT
Reference: CFP129P25
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:53

Manufacturer products View details

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IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525994
Basic UDI-DI: 868511580PCR129GT
Reference: CFP129P50
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:53

Manufacturer products View details

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IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214526007
Basic UDI-DI: 868511580PCR129GT
Reference: CFP129P100
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:53

Manufacturer products View details

Respiratory Pathogens Combo Testing Kit

Respiratory Pathogens Combo Testing Kit

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931305066
Basic UDI-DI: B-06955931305066
Reference: 212801
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus （COVID-19）Multiplex 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: 06955792741522
Basic UDI-DI: B-06955792741522
Reference: S3326E-24
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:31

Manufacturer products Authorised representative products Authorised representative actors View details

Multiple Respiratory Pathogens 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: 06955792732735
Basic UDI-DI: B-06955792732735
Reference: S3163E-48
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

Multiple Respiratory Pathogens 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: 06955792732728
Basic UDI-DI: B-06955792732728
Reference: S3163E-24
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX 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

SARS-CoV-2, Influenza Viruses and Respiratory Syncytial Virus Multiple 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: 06955792732582
Basic UDI-DI: B-06955792732582
Reference: S3325E-24
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX 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