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SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref S3120E-5-H
Identity
- Device Name
- SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) EUDAMED
- Model / Reference
- S3120E-5-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792732650 EUDAMED
- Basic UDI-DI
- B-06955792732650 EUDAMED
- EMDN Code
- W0105040619 EUDAMEDW0105041101 CORONAVIRUS AG EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) by Sansure Biotech Inc. — Class IVD devices for self-testing — 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-06955792732650 | Class IVD devices for self-testing | 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 706ee967-804c-4805-9d14-06a00a15fc3b 61 fields · synced Jun 18, 2026
- EUDAMED 6474aa96-59dd-46d7-9819-5275d560a023 61 fields · synced Jun 11, 2026