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Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (swab)
EUDAMEDClass IVD General (EU MDR)
Ref A211301D
Identity
- Trade Name
- Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (swab) EUDAMED
- Model / Reference
- A211301D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753473252 EUDAMED
- Basic UDI-DI
- B-06976753473252 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 (2019-nCOV) Antigen Rapid Test Cassette (swab) by Hangzhou Cybereagen Biotech Co., Ltd. — 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-06976753473252 | 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 87b41bcc-412b-4c56-b9d7-a5575e20cdf7 61 fields · synced Jun 20, 2026