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06955792735811

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

06955792735804

SARS-CoV-2 S-RBD Antibody ELISA Assay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735804
Basic UDI-DI: B-06955792735804
Reference: S3273E-96
EMDN: W0105040619
EMDN description: CORONAVIRUS
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

06955792735798

SARS-CoV-2 Neutralizing Antibody ELISA Assay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735798
Basic UDI-DI: B-06955792735798
Reference: S3272E-96
EMDN: W0105040619
EMDN description: CORONAVIRUS
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

06955792735781

SARS-CoV-2 Nucleocapsid Protein/Spike Glycoprotein Antibody Rapid Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735781
Basic UDI-DI: B-06955792735781
Reference: S3215E-25
EMDN: W0105040619
EMDN description: CORONAVIRUS
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

06955792735774

Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (RT-Digital PCR)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735774
Basic UDI-DI: B-06955792735774
Reference: S3291E-48
EMDN: W0105040519
EMDN description: CORONAVIRUS - 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

06955792735767

Human EGFR Gene E746_A750 Deletion Mutation Detection Kit (Digital PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735767
Basic UDI-DI: B-06955792735767
Reference: S3290E-24
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
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

06955792735750

Human EGFR Gene L858R Mutation Detection Kit (Digital PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735750
Basic UDI-DI: B-06955792735750
Reference: S3289E-24
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
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

06955792735743

Human ALDH2 and ADH1B Genetic Polymorphism Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735743
Basic UDI-DI: B-06955792735743
Reference: S3212E-24
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
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

06955792735736

Masern virus, Rubella virus, and Mumps virus 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: 06955792735736
Basic UDI-DI: B-06955792735736
Reference: S3279E-48
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - 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

06955792735729

Masern virus, Rubella virus, and Mumps virus 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: 06955792735729
Basic UDI-DI: B-06955792735729
Reference: S3279E-24
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - 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

06955792735712

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

06955792735705

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

06955792735699

Salmonella Typhi and Salmonella Paratyphoid 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: 06955792735699
Basic UDI-DI: B-06955792735699
Reference: S3282E-48
EMDN: W0105011003
EMDN description: SALMONELLA DETECTION BY 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

06955792735682

Salmonella Typhi and Salmonella Paratyphoid 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: 06955792735682
Basic UDI-DI: B-06955792735682
Reference: S3282E-24
EMDN: W0105011003
EMDN description: SALMONELLA DETECTION BY 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

06955792735675

Haemophilus influenzae (HI) 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: 06955792735675
Basic UDI-DI: B-06955792735675
Reference: S3280E-48
EMDN: W0105011610
EMDN description: HAEMOPHILUS INFLUENZAE - 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

06955792735644

Poliovirus type 1, type 2, and type 3 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: 06955792735644
Basic UDI-DI: B-06955792735644
Reference: S3271E-48
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
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

06955792735620

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

06955792735637

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: 06955792735637
Basic UDI-DI: B-06955792735637
Reference: S3269E-48
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

06955792735606

Six Bacterial Meningitis 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: 06955792735606
Basic UDI-DI: B-06955792735606
Reference: S3268E-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

06955792735613

Six Bacterial Meningitis 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: 06955792735613
Basic UDI-DI: B-06955792735613
Reference: S3268E-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 22:09

Manufacturer products Authorised representative products Authorised representative actors View details