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SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Colloidal Gold Method)
EUDAMEDClass IVD General (EU MDR)
Ref S3305E-25Ref 808155-1
Identity
- Device Name
- SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Colloidal Gold Method) EUDAMEDSARS-CoV-2/InFluA/InFluB Antigen Rapid Test (Colloidal Gold) EUDAMED
- Model / Reference
- S3305E-25 EUDAMED808155-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792740877 EUDAMEDD-808155-1BE EUDAMED
- Basic UDI-DI
- B-06955792740877 EUDAMEDB-808155-1BE EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMEDW0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMEDGermany 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/InFluA/InFluB Rapid Antigen Test (Colloidal Gold Method) 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-06955792740877 | 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 21fcbb34-240a-4a5f-b8e5-a6268345e076 61 fields · synced Aug 5, 2026
- EUDAMED 6a178dc3-2eba-4c07-b2b7-7a34f3220c86 61 fields · synced Aug 5, 2026