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Diagnostic Kit for Influenza A (H1N1) Virus（PCR-Fluorescence Probing）
EUDAMEDClass IVD General (EU MDR)
Ref S3156E-24Ref S3156E-48
Identity
- Trade Name
- Diagnostic Kit for Influenza A (H1N1) Virus（PCR-Fluorescence Probing） EUDAMED
- Device Name
- Diagnostic Kit for Influenza A (H1N1) Virus（PCR-Fluorescence Probing） EUDAMED
- Model / Reference
- S3156E-24 EUDAMEDS3156E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792732568 EUDAMED06955792732575 EUDAMED
- Basic UDI-DI
- B-06955792732568 EUDAMEDB-06955792732575 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
Diagnostic Kit for Influenza A (H1N1) Virus（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-06955792732568 | 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 8294d951-da03-4cdf-aefc-cf72a3646de2 61 fields · synced Jul 26, 2026
- EUDAMED 91d29b60-504d-4ee7-bfca-dc9ad91a26f8 61 fields · synced May 19, 2026