GGT - Gamma GT / Gamma GT (SZASZ)
Ref CAEB426
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08056216733203 08056216733203 | Date28 Sep 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- GGT - Gamma GT / Gamma GT (SZASZ) Sphera R1:4x40mL + R2:4x10mL - 800 Test
- Model / Reference
- CAEB426
- Primary DI / UDI-DI
- 08056216733203
- Basic UDI-DI
- B-08056216733203
- EMDN Code
- W01010116 Gamma glutamyltransferase
- Device Class
- Class IVD General
- EU 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