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Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescen…
EUDAMEDClass IVD General (EU MDR)
Ref S3149E-48Ref S3149E-24
Identity
- Device Name
- Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) EUDAMED
- Model / Reference
- S3149E-48 EUDAMEDS3149E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792732193 EUDAMED06955792732186 EUDAMED
- Basic UDI-DI
- B-06955792732193 EUDAMEDB-06955792732186 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
Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescen… 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-06955792732193 | 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 cfd682e3-2d89-4fd8-9867-a4e944a0dc31 61 fields · synced Oct 6, 2026
- EUDAMED dd80c238-8d65-498c-9fe0-55385fb427a4 61 fields · synced May 17, 2026