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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

06955792735934

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: 06955792735934
Basic UDI-DI: B-06955792735934
Reference: S3134E-1
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

06955792735897

SARS-CoV-2 Nucleic Acid Diagnostic Kit (RT-LAMP)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735897
Basic UDI-DI: B-06955792735897
Reference: S3281E-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

06955792735880

SARS-CoV-2 Nucleic Acid Diagnostic Kit (RT-LAMP)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735880
Basic UDI-DI: B-06955792735880
Reference: S3281E-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

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

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

06955792735538

SARS-CoV-2 Neutralizing Antibody Test Kit (ICA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735538
Basic UDI-DI: B-06955792735538
Reference: S3135E-25
EMDN: W0105040619
EMDN description: CORONAVIRUS
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

06955792735521

SARS-CoV-2 Neutralizing Antibody Test Kit (ICA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735521
Basic UDI-DI: B-06955792735521
Reference: S3135E-5
EMDN: W0105040619
EMDN description: CORONAVIRUS
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

06955792735514

SARS-CoV-2 Neutralizing Antibody Test Kit (ICA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735514
Basic UDI-DI: B-06955792735514
Reference: S3135E-1
EMDN: W0105040619
EMDN description: CORONAVIRUS
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

06955792735507

Nipah 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: 06955792735507
Basic UDI-DI: B-06955792735507
Reference: S3284E-48
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
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

06955792735491

Nipah 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: 06955792735491
Basic UDI-DI: B-06955792735491
Reference: S3284E-24
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
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

06955792735361

Astrovirus 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: 06955792735361
Basic UDI-DI: B-06955792735361
Reference: S3228E-48
EMDN: W0105040501
EMDN description: ADENOVIRUS - 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

06955792735354

Astrovirus 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: 06955792735354
Basic UDI-DI: B-06955792735354
Reference: S3228E-24
EMDN: W0105040501
EMDN description: ADENOVIRUS - 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

06955792735309

Yellow fever virus RNA 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: 06955792735309
Basic UDI-DI: B-06955792735309
Reference: S3190E-24
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735293

BK Virus DNA 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: 06955792735293
Basic UDI-DI: B-06955792735293
Reference: S3185E-24
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details