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Adenovirus Rapid Antigen Test (Colloidal Gold Method)
EUDAMEDClass IVD General (EU MDR)
Ref S3348E-50Ref S3348E-1Ref S3348E-25
Identity
- Device Name
- Adenovirus Rapid Antigen Test (Colloidal Gold Method) EUDAMED
- Model / Reference
- S3348E-50 EUDAMEDS3348E-1 EUDAMEDS3348E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792732308 EUDAMED06955792732285 EUDAMED06955792732292 EUDAMED
- Basic UDI-DI
- B-06955792732308 EUDAMEDB-06955792732285 EUDAMEDB-06955792732292 EUDAMED
- EMDN Code
- W0105040601 ADENOVIRUS 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
Adenovirus Rapid Antigen Test (Colloidal Gold Method) by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06955792732308 | 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 (3)
- EUDAMED 3c7d6a9c-3658-456e-95c6-ce819a85b28f 61 fields · synced Jul 13, 2026
- EUDAMED fa7f4b2b-6b51-40f4-98b1-f5bf3dd5e8ea 61 fields · synced May 18, 2026
- EUDAMED fd090248-f1ba-42f1-9c6e-45f57d190919 61 fields · synced May 18, 2026