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Novel Coronavirus (SARS-CoV-2)/Respiratory Pathogens Multiplex Panel Nucleic Ac…
EUDAMEDClass IVD General (EU MDR)
Ref S3112E-48Ref S3112E-24
Identity
- Trade Name
- Novel Coronavirus (SARS-CoV-2)/Respiratory Pathogens Multiplex Panel Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Novel Coronavirus (SARS-CoV-2)/Respiratory Pathogens Multiplex Panel Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3112E-48 EUDAMEDS3112E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792733442 EUDAMED06955792733435 EUDAMED
- Basic UDI-DI
- B-06955792733442 EUDAMEDB-06955792733435 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
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Novel Coronavirus (SARS-CoV-2)/Respiratory Pathogens Multiplex Panel Nucleic Ac… 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-06955792733442 | 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 66ca484e-c075-431d-a2b5-d51fb0e4228b 61 fields · synced Jul 11, 2026
- EUDAMED 263e359c-7b3e-4aa8-baee-7dd693a45772 61 fields · synced May 19, 2026