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SARS-CoV-2 T478K Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref S3146E-24Ref S3146E-48
Identity
- Device Name
- SARS-CoV-2 T478K Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3146E-24 EUDAMEDS3146E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792734616 EUDAMED06955792734623 EUDAMED
- Basic UDI-DI
- B-06955792734616 EUDAMEDB-06955792734623 EUDAMED
- EMDN Code
- W0105040619 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
SARS-CoV-2 T478K Mutation Nucleic Acid 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-06955792734616 | 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 84d7f83b-012f-4ef1-ad18-b3e6031bba1a 61 fields · synced Jul 10, 2026
- EUDAMED 15f5351d-df37-4061-b5e1-a10e09807e0e 61 fields · synced May 17, 2026