A1c Cal- Emoglobina Glicata CAL 4Liv. / Glycated Hemoglobin CAL 4Lev.
Ref CCS452
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-08056216739533 08056216739533 | Date19 Oct 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- Withdrawn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
- Model / Reference
- CCS452
- Primary DI / UDI-DI
- 08056216739533
- Basic UDI-DI
- B-08056216739533
- EMDN Code
- W01010214 Glycosylated/glycated haemoglobin (cc)
- Device Class
- Class IVD General
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- IT-MF-000026483
Other devices from Sanymed s.a.s.
Properties
Other properties (7)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No