SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)
by Anhui Deepblue Medical Technology Co., Ltd 8 variants
Ref CFRA1ST-2Model Cassette
Active
CE IVDR
Valid until
21 Mar 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberEU-TDA-FI-20642-800030-2025-1 | Date9 Jun 2026 | StatusActive |
Certificates
- EU-TDA-FI-20642-800030-2025-1 Active
Technical documentation EU IVDR
- Certifier
- Kiwa Sertio Oy 3018
- Issued
- 9 Jun 2026
- Expires
- 21 Mar 2030
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Cassette, CFRA1ST-2
- Primary DI / UDI-DI
- 06952062774082
- Basic UDI-DI
- 69520627J034LD
- Unit of Use DI
- 06952062712732
- EMDN Code
- W0105099099 Virology - rt & poc - other
- Device Class
- Class C
- 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
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No