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SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isoth…

EUDAMED

Class IVD General (EU MDR)

Ref S3344E-1Ref S3113E-24

by Sansure Biotech Inc.

Identity

Trade Name
SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
Device Name
SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification) EUDAMED
SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
Model / Reference
S3344E-1 EUDAMED
S3113E-24 EUDAMED

Identifiers

Primary DI / UDI-DI
06955792743380 EUDAMED
06955792731325 EUDAMED
Basic UDI-DI
B-06955792743380 EUDAMED
B-06955792731325 EUDAMED
EMDN Code
W0105070302 OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS EUDAMED
W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isoth… by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Sansure Biotech Inc.
EUDAMED SRN
CN-MF-000011392
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (2)

  • EUDAMED d719262d-932f-47e6-8524-8480eb1e83db 61 fields · synced Jul 12, 2026
  • EUDAMED 89be2dea-0f32-4a98-894a-45635093df45 61 fields · synced May 17, 2026