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06955792732643

SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)

IVD self-testing devicesIVDDNo longer on the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732643
Basic UDI-DI: B-06955792732643
Reference: S3120E-1-H
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732605

SARS-CoV-2 BA.1/BA.2 Mutation 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: 06955792732605
Basic UDI-DI: B-06955792732605
Reference: S3340E-48
EMDN: W0105040519
EMDN description: CORONAVIRUS - 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

06955792732599

SARS-CoV-2 BA.1/BA.2 Mutation 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: 06955792732599
Basic UDI-DI: B-06955792732599
Reference: S3340E-24
EMDN: W0105040519
EMDN description: CORONAVIRUS - 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

Diagnostic Kit for Influenza A (H1N1) Virus（PCR-Fluorescence Probing）

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732575
Basic UDI-DI: B-06955792732575
Reference: S3156E-48
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - 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

Diagnostic Kit for Influenza A (H1N1) Virus（PCR-Fluorescence Probing）

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732568
Basic UDI-DI: B-06955792732568
Reference: S3156E-24
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - 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

06955792732476

Influenza A Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732476
Basic UDI-DI: B-06955792732476
Reference: S3275E-24
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - 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

06955792732469

Human Herpes Virus 7 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: 06955792732469
Basic UDI-DI: B-06955792732469
Reference: S3181E-24
EMDN: W0105040519
EMDN description: CORONAVIRUS - 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

06955792732377

Mycoplasma genitalium DNA Diagnostic Kit（PCR-Fluorescence Probing）

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732377
Basic UDI-DI: B-06955792732377
Reference: S3065E
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma genitalium DNA Diagnostic Kit（PCR-Fluorescence Probing）

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732360
Basic UDI-DI: B-06955792732360
Reference: S3065E
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732353

Talaromyces marneffei DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732353
Basic UDI-DI: B-06955792732353
Reference: S3337E-48
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732346

Talaromyces marneffei DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732346
Basic UDI-DI: B-06955792732346
Reference: S3337E-24
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue Fever Virus General-type Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732339
Basic UDI-DI: B-06955792732339
Reference: S3060E
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732308

Adenovirus Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732308
Basic UDI-DI: B-06955792732308
Reference: S3348E-50
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732292

Adenovirus Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732292
Basic UDI-DI: B-06955792732292
Reference: S3348E-25
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732285

Adenovirus Rapid Antigen Test (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732285
Basic UDI-DI: B-06955792732285
Reference: S3348E-1
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732278

Severe Fever With Thrombocytopenia Syndrome Bunyavirus 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: 06955792732278
Basic UDI-DI: B-06955792732278
Reference: S3189E-24
EMDN: W0105040514
EMDN description: HANTAVIRUS / BUNYAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732261

Human Coronavirus (MERS) 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: 06955792732261
Basic UDI-DI: B-06955792732261
Reference: S3174E-24-P
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732254

Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732254
Basic UDI-DI: B-06955792732254
Reference: S3174E-48
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732247

Human Coronavirus (MERS) 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: 06955792732247
Basic UDI-DI: B-06955792732247
Reference: S3174E-24
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732230

Rabies 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: 06955792732230
Basic UDI-DI: B-06955792732230
Reference: S3193E-24
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details