PocketChem BA (PA-4140)
by ARKRAY Factory, Inc. Japan EUDAMED
Ref 20504 EMDN W0201010203
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-20504F5 | Date20 Apr 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- 20504
- Primary DI / UDI-DI
- D-20504F5
- Basic UDI-DI
- B-20504F5
- EMDN Code
- W0201010203 Blood-ammonia checkers
- 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 3cd5b56f-ad63-4349-bb45-50d9d65f9755