COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
by Anhui Deepblue Medical Technology Co., Ltd 8 variants
Ref COVAg1NNO3-5Model Cassette
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69520627J013L5 06952062713890 | Date7 Aug 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Cassette, COVAg1NNO3-5
- Primary DI / UDI-DI
- 06952062713890
- Basic UDI-DI
- 69520627J013L5
- Unit of Use DI
- 06952062713944
- EMDN Code
- W0105099099 Virology - rt & poc - other
- Device Class
- Class B
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000018785
- Authorised representative
- Mega Eurostar Sp. z o.o. PL-AR-000042730
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No