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Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)
EUDAMEDClass IVD General (EU MDR)
Ref A361301D
Identity
- Trade Name
- Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) EUDAMED
- Model / Reference
- A361301D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753474877 EUDAMED
- Basic UDI-DI
- B-06976753474877 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) by Hangzhou Cybereagen Biotech Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06976753474877 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000037850
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e2cf6ea5-15c4-43cc-a1b2-fceb55625c7f 61 fields · synced Oct 6, 2026