Device
001.000.005 (with TÜV SÜD safety mark)
Manufacturer
Adaptive Sensory Technology, Inc.
Adaptive Sensory Technology, Inc.
Model: 001.000.005 (with TÜV SÜD safety mark)
DI: 00850067216025
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bd67efb4-a9f1-4408-959e-99ebaafe0886
Distribution Status:
In Commercial Distribution
DUNS Number:
067936644
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850067216025
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35922
Name: Visual acuity projector
Definition:
A mains electricity (AC-powered) ophthalmic device intended to project an image on a screen to test visual acuity. The images typically include block letters (Snellen chart) and/or other symbols (e.g., recognizable objects used for children who cannot read) viewed in gradually decreasing size. They are typically identified according to the distance at which they are ordinarily visible (normally 6 metres or 20 feet).
FDA Product Codes
QTO
Digital Visual Acuity Test