Astrovirus Test Cassette
by Acro Biotech Inc. EUDAMED
Active
Ref acrAS602F
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-acrAS602FRJ | Date21 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- acrAS602F
- Primary DI / UDI-DI
- D-acrAS602FRJ
- Basic UDI-DI
- B-acrAS602FRJ
- EMDN Code
- W0105099099 Virology - rt & poc - other
- Device Class
- Class IVD General
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- US-MF-000017832
- Authorised representative
- VidaQuick Biotech S.L. ES-AR-000048138
Other devices from ACRO BIOTECH Inc.
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No