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SARS-CoV-2 Rapid Antigen Test (Saliva)
EUDAMEDClass IVD General (EU MDR)
Ref S3134E-5Ref S3134E-1
Identity
- Device Name
- SARS-CoV-2 Rapid Antigen Test (Saliva) EUDAMED
- Model / Reference
- S3134E-5 EUDAMEDS3134E-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792735941 EUDAMED06955792735934 EUDAMED
- Basic UDI-DI
- B-06955792735941 EUDAMEDB-06955792735934 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
Yes
EUDAMED
Microbial Substances
No
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 Rapid Antigen Test (Saliva) is a medical device used for rapid detection of SARS-CoV-2 antigens in respiratory samples. This easy-to-use test provides quick results, making it an ideal tool for healthcare professionals and non-medical personnel looking to quickly identify COVID-19 cases.
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-06955792735941 | 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 0344e0d9-6078-4f61-a890-993c98edfd12 61 fields · synced Jul 15, 2026
- EUDAMED 971d5778-a5bb-45fb-ab6e-6f4debf5c4c3 61 fields · synced May 18, 2026