← Back to catalogue
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection …
EUDAMEDClass IVD General (EU MDR)
Ref C8611CARef C8611C
Identity
- Trade Name
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) EUDAMED
- Device Name
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) EUDAMED
- Model / Reference
- C8611CA EUDAMEDC8611C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315730518 EUDAMED
- Basic UDI-DI
- B-06973315730518 EUDAMED
- EMDN Code
- W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection … by Nanjing Vazyme Medical Technology Co., Ltd. — Class IVD General — IVDD…
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-06973315730518 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED cfb646a3-aff4-4570-8649-964afecef1ec 61 fields · synced Oct 9, 2026
- EUDAMED 57a61491-3098-4bcd-8786-22c6e8e11f09 61 fields · synced Jun 19, 2026