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Influenza BV/BY RNA Diagnostic Kit（PCR-Fluorescence Probing）
EUDAMEDClass IVD General (EU MDR)
Ref S3165E-48Ref S3165E-24
Identity
- Trade Name
- Influenza BV/BY RNA Diagnostic Kit（PCR-Fluorescence Probing） EUDAMED
- Device Name
- Influenza BV/BY RNA Diagnostic Kit（PCR-Fluorescence Probing） EUDAMED
- Model / Reference
- S3165E-48 EUDAMEDS3165E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792733794 EUDAMED06955792733787 EUDAMED
- Basic UDI-DI
- B-06955792733794 EUDAMEDB-06955792733787 EUDAMED
- EMDN Code
- W0105040504 INFLUENZA & PARA INFLUENZA - NA REAGENTS 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
Influenza BV/BY RNA Diagnostic Kit（PCR-Fluorescence Probing） 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-06955792733794 | 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 3d7b16d6-8967-43b0-8f16-17b4d0957904 61 fields · synced Jul 24, 2026
- EUDAMED 43e8b4c6-7143-4010-8237-36344f1e407d 61 fields · synced May 17, 2026