Aution Max (Ax-4030)
by ARKRAY Factory, Inc. Japan EUDAMED
Ref 14504
EMDN W020101020103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-14504FN | Date11 May 2022 | StatusWithdrawn |
Coverage
- Withdrawn
- Not covered
European Union — CE/IVDD Withdrawn
Specification
- Model / Reference
- 14504
- Primary DI / UDI-DI
- D-14504FN
- Basic UDI-DI
- B-14504FN
- EMDN Code
- W020101020103 Automated urine analysers
- Device Class
- Class IVD General
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- JP-MF-000003008
- Authorised representative
- ARKRAY Europe, B.V. NL-AR-000002056
Other devices from ARKRAY Factory, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
Sources (1)
- EUDAMED fd6e6690-92a7-4a9c-8781-d411833e3e82