AutoChem ALP
by Autobio Biochemistry Co., Ltd EUDAMED
Active
Ref 360101ALP000SModel Automatic Chemistry Analyzer
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69422530000005N8 | Date25 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Model / Reference
- Automatic Chemistry Analyzer, 360101ALP000S
- Primary DI / UDI-DI
- 06942253000427
- Basic UDI-DI
- 69422530000005N8
- EMDN Code
- W01010105 Alkaline phosphatase - total
- Device Class
- Class C
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000038143
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Autobio Biochemistry Co., Ltd
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No