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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525970
Basic UDI-DI: 868521452PCR162GA
Reference: CFP162P100
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:54

Manufacturer products View details

VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440227700
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY106LE
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:54

Manufacturer products View details

VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440227748
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY106HE
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:54

Manufacturer products View details

VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440227717
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY112LE
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:54

Manufacturer products View details

VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440227755
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY112HE
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:54

Manufacturer products View details

VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440227724
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY113LE
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:54

Manufacturer products View details

VIASURE Salmonella, Campylobacter & Y. enterocolitica 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: 08435440227762
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY113HE
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:54

Manufacturer products View details

VIASURE Salmonella, Campylobacter & Y. enterocolitica Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440227847
Basic UDI-DI: 84354402_MDXGASTROB_SCYT3
Reference: VS-SCY196TE
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:54

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: 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

Japanese Encephalitis Virus/Tick-Borne Encephalitis Virus/West Nile Virus/Dengue Virus (JEV/TBEV/WNV/DFV) 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: 06955792735828
Basic UDI-DI: B-06955792735828
Reference: S3285E-48
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

Japanese Encephalitis Virus/Tick-Borne Encephalitis Virus/West Nile Virus/Dengue Virus (JEV/TBEV/WNV/DFV) 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: 06955792735811
Basic UDI-DI: B-06955792735811
Reference: S3285E-24
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

5 Encephalitis related Viruses 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: 06955792735712
Basic UDI-DI: B-06955792735712
Reference: S3286E-48
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

5 Encephalitis related Viruses 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: 06955792735705
Basic UDI-DI: B-06955792735705
Reference: S3286E-24
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

4 HFMD related 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: 06955792735620
Basic UDI-DI: B-06955792735620
Reference: S3269E-24
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details