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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

06955792735590

Varicella-Zoster Virus/Enterovirus (VZV/EV) 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: 06955792735590
Basic UDI-DI: B-06955792735590
Reference: S3265E-48
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - 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

06955792735583

Varicella-Zoster Virus/Enterovirus (VZV/EV) 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: 06955792735583
Basic UDI-DI: B-06955792735583
Reference: S3265E-24
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - 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

06955792735576

Group A Streptococcus (GAS) 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: 06955792735576
Basic UDI-DI: B-06955792735576
Reference: S3260E-48
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY 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

06955792735569

Group A Streptococcus (GAS) 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: 06955792735569
Basic UDI-DI: B-06955792735569
Reference: S3260E-24
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY 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

06955792735552

Japanese Encephalitis 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: 06955792735552
Basic UDI-DI: B-06955792735552
Reference: S3253E-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

06955792735545

Japanese Encephalitis 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: 06955792735545
Basic UDI-DI: B-06955792735545
Reference: S3253E-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 22:09

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

06955792735484

Forest encephalitis 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: 06955792735484
Basic UDI-DI: B-06955792735484
Reference: S3258E-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

06955792735477

Forest encephalitis 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: 06955792735477
Basic UDI-DI: B-06955792735477
Reference: S3258E-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 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735460

Vibrio Parahaemolyticus 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: 06955792735460
Basic UDI-DI: B-06955792735460
Reference: S3208E-48
EMDN: W0105011699
EMDN description: BACTERIOLOGY - 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

06955792735453

Vibrio Parahaemolyticus 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: 06955792735453
Basic UDI-DI: B-06955792735453
Reference: S3208E-24
EMDN: W0105011699
EMDN description: BACTERIOLOGY - 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

06955792735446

Helicobacter pylori Clarithromycin resistant 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: 06955792735446
Basic UDI-DI: B-06955792735446
Reference: S3207E-48
EMDN: W0105010499
EMDN description: H. PYLORI 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

06955792735439

Helicobacter pylori Clarithromycin resistant 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: 06955792735439
Basic UDI-DI: B-06955792735439
Reference: S3207E-24
EMDN: W0105010499
EMDN description: H. PYLORI 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