Cistatina C
Ref 7797
Cistatina C (7797) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category cystatin c) made by Giesse Diagnostics SRL, registered in EUDAMED on 31 Mar 2026 (Basic UDI-DI B-08053172971915), active as of 22 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08053172971915 08053172971915 | Date31 Mar 2026 | StatusActive |
Official records
- EUDAMED public site B-08053172971915
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- Withdrawn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
- Cistatina C/Cystatin C
- Model / reference
- 7797
- Primary DI / UDI-DI
- 08053172971915
- Basic UDI-DI
- B-08053172971915
- EMDN code
- W0102019008 Cystatin c
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000039031
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- K-ASSAY Cystatin C Calibrator KAI-200C by KAMIYA BIOMEDICAL COMPANY, LLC
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- K-ASSAY Cystatin C Control K200C-2M by KAMIYA BIOMEDICAL COMPANY, LLC
- BGI MFG030065 by BGI EUROPE A/S
- Cys C rapid test cassette (Rare earth nano fluorescence immunochromatography) IF053 by Beijing Applied Biological Technologies Co., Ltd.