Identity
- Trade Name
- VISUCORE 500 System EUDAMED
- Device Name
- VISUCORE 500 System EUDAMED
- Model / Reference
- 000000-2548-409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250668607219 EUDAMED
- Basic UDI-DI
- 42506686-B01-VCR500S-5K EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- "VISUCORE 500 System is a combined refraction device that includes VISUCORE 500 Refractor, VISUSCREEN 100 Compact and a dedicated table. VISUCORE 500 Refractor consists of a binocular wavefront aberrometer, a phoropter head for subjective refraction and a display for near reading tests. With the product the prescription for nonimplantable wearable optical correction can be determined. VISUSCREEN 100 Compact is a chart display that is used in short refraction distance of approximately 1 m with a system that simulates infinity. To enable the required refraction distance (of infinity) of minimum 4 m, the chart display is mounted in a box that uses path-folding mirrors inside to project the charts to the patient." EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
VISUCORE 500 System by Carl Zeiss Vision Gmbh — Class IIa — 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 | 42506686-B01-VCR500S-5K | Class IIa | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Vision GmbH
- EUDAMED SRN
- DE-PR-000040411
Sources (1)
- EUDAMED 1b8c8a71-8dd6-4431-b552-c3109c317f95 61 fields · synced Jul 25, 2026