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06955792732728

Multiple Respiratory 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: 06955792732728
Basic UDI-DI: B-06955792732728
Reference: S3163E-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 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732711
Basic UDI-DI: B-06955792732711
Reference: S3214E-48
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
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

Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732704
Basic UDI-DI: B-06955792732704
Reference: S3214E-24
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
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

06955792732674

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: 06955792732674
Basic UDI-DI: B-06955792732674
Reference: S3120E-25-H
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
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

06955792732667

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: 06955792732667
Basic UDI-DI: B-06955792732667
Reference: S3120E-10-H
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
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

06955792732650

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: 06955792732650
Basic UDI-DI: B-06955792732650
Reference: S3120E-5-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

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

06955792732636

Cryptosporidium/Entamoeba histolytica/Giardia lamblia 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: 06955792732636
Basic UDI-DI: B-06955792732636
Reference: S3227E-48
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
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

06955792732629

Cryptosporidium/Entamoeba histolytica/Giardia lamblia 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: 06955792732629
Basic UDI-DI: B-06955792732629
Reference: S3227E-24
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
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

Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732612
Basic UDI-DI: B-06955792732612
Reference: S3096E
EMDN: W0105011804
EMDN description: C.DIFFICILE BY 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

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

06955792732582

SARS-CoV-2, Influenza Viruses and Respiratory Syncytial Virus Multiple 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: 06955792732582
Basic UDI-DI: B-06955792732582
Reference: S3325E-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 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

06955792732551

Measles and Rubella virus (MeV/RV) RNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732551
Basic UDI-DI: B-06955792732551
Reference: S3278E-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 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732544

Measles and Rubella virus (MeV/RV) RNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732544
Basic UDI-DI: B-06955792732544
Reference: S3278E-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 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732537

Streptococcus suis DNA Diagnostic Kit（PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732537
Basic UDI-DI: B-06955792732537
Reference: S3254E-48
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
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

06955792732520

Streptococcus suis DNA Diagnostic Kit（PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732520
Basic UDI-DI: B-06955792732520
Reference: S3254E-24
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
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

06955792732513

Helicobacter pylori typingl 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: 06955792732513
Basic UDI-DI: B-06955792732513
Reference: S3205E-48
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY 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