Identity
- Trade Name
- CYSTATIN C EUDAMEDCYSTATIN C CONTROL EUDAMED
- Device Name
- CYSTATIN C EUDAMEDCYSTATIN C CONTROL EUDAMED
- Model / Reference
- 1418-0596 EUDAMED1478-0591 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309152292 EUDAMED05204309123384 EUDAMED
- Basic UDI-DI
- B-05204309152292 EUDAMEDB-05204309123384 EUDAMED
- EMDN Code
- W0102019008 CYSTATIN C EUDAMEDW0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Cystatin C by Medicon Hellas SA — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05204309152292 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (2)
- EUDAMED 62daba8a-f029-4d0e-ba70-ba03a3563366 61 fields · synced Jul 11, 2026
- EUDAMED 3e6a059d-13ba-402e-b410-974de1e2c419 61 fields · synced May 17, 2026