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SARS-CoV-2 L452R/E484Q/P681R/E484K Mutation Nucleic Acid Detection Kit ( PCR-Fl…
EUDAMEDClass IVD General (EU MDR)
Ref S3128E-48Ref S3128E-24
Identity
- Device Name
- SARS-CoV-2 L452R/E484Q/P681R/E484K Mutation Nucleic Acid Detection Kit ( PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- S3128E-48 EUDAMEDS3128E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792735965 EUDAMED06955792735958 EUDAMED
- Basic UDI-DI
- B-06955792735965 EUDAMEDB-06955792735958 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
SARS-CoV-2 L452R/E484Q/P681R/E484K Mutation Nucleic Acid Detection Kit ( PCR-Fl… 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-06955792735965 | 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 c8c8fd56-755d-4f55-b02f-0e73f9370505 61 fields · synced Jul 22, 2026
- EUDAMED 53f5727c-962a-4191-86b3-c1beb0e3fd3b 61 fields · synced May 19, 2026