Ast - Got-Ast / Ast-Got (Ifcc)
by Sanymed s.a.s. EUDAMED
Active
Ref CCS094
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08056216733579 | Date5 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- AST - GOT-AST / AST-GOT (IFCC) BT Line R1:4x50mL + R2:4x12,5mL - 1000 Test
- Model / Reference
- CCS094
- Primary DI / UDI-DI
- 08056216733579
- Basic UDI-DI
- B-08056216733579
- EMDN Code
- W01010110 Aspartate amino-transferase
- Device Class
- Class IVD General
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000026483
Other devices from Sanymed s.a.s.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No