Identity
- Trade Name
- VisionOne System EUDAMED
- Device Name
- Perimetry system EUDAMED
- Model / Reference
- 016.001.005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640255020694 EUDAMED
- Basic UDI-DI
- 764025502TD016S22 EUDAMED
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The VisionOne System is intended to facilitate perimetry visual field eye tests with the VisionOne medical device software running on a virtual reality (VR) headset to aid in the detection, diagnosis and monitoring of ocular and neurological diseases. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
VisionOne System by Effectum Medical AG — 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 | 764025502TD016S22 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Effectum Medical AG
- EUDAMED SRN
- CH-PR-000043014
Sources (1)
- EUDAMED 0e53a8f4-1394-480a-8c90-7169f274b792 61 fields · synced Jun 18, 2026