← Back to catalogue
REFRACTION SYSTEM Chronos
EUDAMEDClass I (EU MDR)
Ref ChronosModel REFRACTION SYSTEM Chronos
Identity
- Trade Name
- REFRACTION SYSTEM Chronos EUDAMED
- Device Name
- Chronos EUDAMED
- Model / Reference
- REFRACTION SYSTEM Chronos EUDAMEDChronos EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560126268341 EUDAMED
- Basic UDI-DI
- 4560126260500UG EUDAMED
- EMDN Code
- Z12120115 OPTOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The Chronos measures the spherical refractive power, cylindrical refractive power, and astigmatism axis direction of the eyeball. The curvature radius of the corneal surface is measured. In addition, various subjective refraction acuity examinations are performed. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
REFRACTION SYSTEM Chronos by Topcon Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4560126260500UG | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-PR-000041957
Sources (1)
- EUDAMED 0a8c6255-9070-441b-84ed-1e08a4368b27 61 fields · synced Jun 20, 2026