← Back to catalogue
Novel Coronavirus (2019-nCoV) Multiplex Nucleic Acid Diagnostic Kit (PCR Fluore…
EUDAMEDClass IVD General (EU MDR)
Ref S3172E-96Ref S3172E-24Ref S3107E-48
Identity
- Trade Name
- Novel Coronavirus (2019-nCoV) Multiplex Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) EUDAMEDNovel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Novel Coronavirus (2019-nCoV) Multiplex Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) EUDAMEDNovel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3172E-96 EUDAMEDS3172E-24 EUDAMEDS3107E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792733848 EUDAMED06955792733824 EUDAMED06955792733466 EUDAMED
- Basic UDI-DI
- B-06955792733848 EUDAMEDB-06955792733824 EUDAMEDB-06955792733466 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
Novel Coronavirus (2019-nCoV) Multiplex Nucleic Acid Diagnostic Kit (PCR Fluore… 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-06955792733848 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED aa29ec23-3357-4155-9e2d-40ef5f93c2b4 61 fields · synced Jul 30, 2026
- EUDAMED f0ba3b9e-ef77-4804-8168-b18df0650444 61 fields · synced May 17, 2026
- EUDAMED 6c7fd163-52d3-448f-998a-5929b3e4fadf 61 fields · synced May 17, 2026