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SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)
EUDAMEDClass IVD General (EU MDR)
Ref S3343E-15Ref S3343E-1
Identity
- Device Name
- SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification) EUDAMED
- Model / Reference
- S3343E-15 EUDAMEDS3343E-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792743373 EUDAMED06955792743366 EUDAMED
- Basic UDI-DI
- B-06955792743373 EUDAMEDB-06955792743366 EUDAMED
- EMDN Code
- W0105040519 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 Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification) 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06955792743373 | Class IVD General | Active |
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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 87de2d15-4af2-40eb-b478-727774f0b867 61 fields · synced Jul 25, 2026
- EUDAMED 9f98616f-db36-430f-9203-3805911769cf 61 fields · synced May 18, 2026