Identity
- Trade Name
- myVisionTrack FDA UDI
- Generic Name
- Vision self-testing software FDA UDI
- Device Name
- Vision testing application - iOS version FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Vision testing application - iOS version FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003376157 FDA UDI
- FDA Product Code
- QTW FDA UDI
- GMDN Term
- Vision self-testing software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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 self-testing software
myVisionTrack by Brightinsight Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vision self-testing software.
- AMA Optics Digital Vision Test — AMA Optics, Inc. · Class I
- Alleye — Oculocare Medical AG · Class I
- myVisionTrack — BRIGHTINSIGHT INC. · Class I
- myVisionTrack — BRIGHTINSIGHT INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Brightinsight Inc.
Sources (1)
- FDA UDI 8f8fa246-d92e-43fc-b22a-62821dd3db27 33 fields · synced May 30, 2026