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Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733411
Basic UDI-DI: B-06955792733411
Reference: S3106E
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Avian influenza virus H3N2 RNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733404
Basic UDI-DI: B-06955792733404
Reference: S3101E
EMDN: W0105040515
EMDN description: AVIAN INFLUENZA - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacterium Multiplex Nucleic Acid Diagnostic Kit(Multiplex PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733398
Basic UDI-DI: B-06955792733398
Reference: S3099E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Human MTHFR and MTRR Genetic Polymorphism Nucleotide Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733381
Basic UDI-DI: B-06955792733381
Reference: S3098E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Human MTHFR and MTRR Genetic Polymorphism Nucleotide Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733374
Basic UDI-DI: B-06955792733374
Reference: S3098E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumoniae Nucleic Acid And Drug Resistence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733367
Basic UDI-DI: B-06955792733367
Reference: S3097E
EMDN: W0105010118
EMDN description: CHLAMYDIA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Avian influenza virus H5 RNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733350
Basic UDI-DI: B-06955792733350
Reference: S3095E
EMDN: W0105040515
EMDN description: AVIAN INFLUENZA - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Avian influenza virus H3 RNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733343
Basic UDI-DI: B-06955792733343
Reference: S3094E
EMDN: W0105040515
EMDN description: AVIAN INFLUENZA - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733336
Basic UDI-DI: B-06955792733336
Reference: S3093E
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Varicella-zoster virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733329
Basic UDI-DI: B-06955792733329
Reference: S3090E
EMDN: W0105040904
EMDN description: VARICELLA ZOSTER - NA REAGENTS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Human SLCO1B1 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733312
Basic UDI-DI: B-06955792733312
Reference: S3087E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Human CYP2C9 and VKORC1 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733305
Basic UDI-DI: B-06955792733305
Reference: S3088E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Human MTHFR Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitMicrobial substancesProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733299
Basic UDI-DI: B-06955792733299
Reference: S3086E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

Human ALDH2 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733282
Basic UDI-DI: B-06955792733282
Reference: S3085E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

Human ApoE Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733275
Basic UDI-DI: B-06955792733275
Reference: S3089E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

Middle East Respiratory Syndrome Coronaviruses Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733268
Basic UDI-DI: B-06955792733268
Reference: S3091E
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

Human CYP2C19 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733251
Basic UDI-DI: B-06955792733251
Reference: S3084E
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

Avian Influenza Virus (H7N9) Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733244
Basic UDI-DI: B-06955792733244
Reference: S3092E
EMDN: W0105040515
EMDN description: AVIAN INFLUENZA - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733237
Basic UDI-DI: B-06955792733237
Reference: S3105E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733220
Basic UDI-DI: B-06955792733220
Reference: S3082E
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details