← Back to catalogue
SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 51332801
Identity
- Trade Name
- SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) EUDAMED
- Device Name
- SARS-CoV-2 Antigen Rapid Test(Colloidal Gold) EUDAMED
- Model / Reference
- 51332801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971100210917 EUDAMED
- Basic UDI-DI
- B-06971100210917 EUDAMED
- EMDN Code
- W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC 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
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) by Xiamen Wiz Biotech Co., Ltd. — 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-06971100210917 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Wiz Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000029590
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED dfb67712-178b-474a-9377-3cd81578bc33 61 fields · synced Jul 23, 2026