← Back to catalogue
REFRACTION SYSTEM Chronos
EUDAMEDClass I (EU MDR)
Ref ChronosModel REFRACTION SYSTEM ChronosRef 1037591-03
Identity
- Trade Name
- REFRACTION SYSTEM Chronos EUDAMED
- Device Name
- Chronos EUDAMEDREFRACTION SYSTEM Chronos EUDAMED
- Model / Reference
- REFRACTION SYSTEM Chronos EUDAMEDChronos EUDAMED1037591-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560126268358 EUDAMEDD-JPMF3928_1037591-03YH EUDAMED
- Basic UDI-DI
- 4560126260500UG EUDAMEDB-JPMF3928_1037591-03YH EUDAMED
- EMDN Code
- Z12120115 OPTOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
REFRACTION SYSTEM Chronos by Topcon Corporation — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4560126260500UG | Class I | Active |
| 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 (2)
- EUDAMED a9ccadba-5d4f-4d54-937c-c99f7cf47667 61 fields · synced Jul 11, 2026
- EUDAMED f21ddd94-ccf9-47ed-be71-61781c1dd70a 61 fields · synced May 19, 2026