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06955792743397

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743397
Basic UDI-DI: B-06955792743397
Reference: S3344E-15
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 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743380

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743380
Basic UDI-DI: B-06955792743380
Reference: S3344E-1
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 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743373

SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743373
Basic UDI-DI: B-06955792743373
Reference: S3343E-15
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743366

SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743366
Basic UDI-DI: B-06955792743366
Reference: S3343E-1
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792742833

SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792742833
Basic UDI-DI: B-06955792742833
Reference: S2150E-150
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

06955792742826

SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792742826
Basic UDI-DI: B-06955792742826
Reference: S2150E-100
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

06955792742819

SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792742819
Basic UDI-DI: B-06955792742819
Reference: S2150E-75
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

06955792742802

SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792742802
Basic UDI-DI: B-06955792742802
Reference: S2150E-50
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

06955792741539

Novel Coronavirus(COVID-19) 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: 06955792741539
Basic UDI-DI: B-06955792741539
Reference: S3327E-24
EMDN: W0105040519
EMDN description: CORONAVIRUS - 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

06955792741522

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

06955792740877

SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792740877
Basic UDI-DI: B-06955792740877
Reference: S3305E-25
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

06955792736047

West Nile 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: 06955792736047
Basic UDI-DI: B-06955792736047
Reference: S3259E-48
EMDN: W0105040526
EMDN description: WEST NILE VIRUS - NA REAGENT
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

06955792736030

West Nile 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: 06955792736030
Basic UDI-DI: B-06955792736030
Reference: S3259E-24
EMDN: W0105040526
EMDN description: WEST NILE VIRUS - NA REAGENT
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

06955792736023

Campylobacter coli 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: 06955792736023
Basic UDI-DI: B-06955792736023
Reference: S3247E-48
EMDN: W0105011402
EMDN description: CAMPYLOBACTER DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

06955792736016

Campylobacter coli 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: 06955792736016
Basic UDI-DI: B-06955792736016
Reference: S3247E-24
EMDN: W0105011402
EMDN description: CAMPYLOBACTER DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

06955792736009

Campylobacter fetus 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: 06955792736009
Basic UDI-DI: B-06955792736009
Reference: S3210E-48
EMDN: W0105011402
EMDN description: CAMPYLOBACTER DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735972

Campylobacter jejuni 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: 06955792735972
Basic UDI-DI: B-06955792735972
Reference: S3209E-24
EMDN: W0105011402
EMDN description: CAMPYLOBACTER DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735965

SARS-CoV-2 L452R/E484Q/P681R/E484K Mutation Nucleic Acid Detection Kit ( PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735965
Basic UDI-DI: B-06955792735965
Reference: S3128E-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

06955792735958

SARS-CoV-2 L452R/E484Q/P681R/E484K Mutation Nucleic Acid Detection Kit ( PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735958
Basic UDI-DI: B-06955792735958
Reference: S3128E-24
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

06955792735941

SARS-CoV-2 Rapid Antigen Test (Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735941
Basic UDI-DI: B-06955792735941
Reference: S3134E-5
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