Identity
- Trade Name
- RightEye Vision System FDA UDI
- Generic Name
- Vision physiology/eye movement analysis system FDA UDI
- Device Name
- RightEye Vision System™ tracks the amplitude and velocity of rapid, involuntary, and oscillatory ocular movements, measuring changes with eye movement. The system records, analyses, and reports eye movements in real-time. FDA UDI
- Model / Reference
- Tobii Dynavox i15 FDA UDI
- Description
- RightEye Vision System™ tracks the amplitude and velocity of rapid, involuntary, and oscillatory ocular movements, measuring changes with eye movement. The system records, analyses, and reports eye movements in real-time. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010031902 FDA UDI
- FDA Product Code
- GWN FDA UDI
- GMDN Term
- Vision physiology/eye movement analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vision physiology/eye movement analysis system
RightEye Vision System by Righteye, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Righteye, LLC
Sources (1)
- FDA UDI 98396f52-8024-467a-a662-719eabacdae9 33 fields · synced May 30, 2026