M&S Technologies ACUITYex
Catalogue number EX-100, listed by The Hilsinger Company Parent, LLC, United States, under Digital Visual Acuity Test. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Fabris Lane Eyewear (Wenzhou) Ltd | Wenzhou | Zhejiang | Specification developer | 6 |
| Langfang FAR East Prosperous Optical Instrument Co., Ltd. | Langfang | Hebei | Contract manufacturer | 5 |
Record
| Listed by | The Hilsinger Company Parent, LLC, United States |
|---|---|
| FDA product code | QTO |
| Device type | Digital Visual Acuity Test |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1150 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-06 |
| Record revised | 2023-12-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Packaging | Ex-pc-sft |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EX-100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Manifold Vision Meter | Adaptive Sensory Technology Inc | 4 |
| AMA Optics Digital Vision Test | AMA Optics, Inc. | 1 |
| Oculus Easyfield VR | The Hilsinger Company Parent, LLC | 1 |
| Vdap | Visibly | 1 |
| M&S Technologies VisiChart® Acuity Chart | The Hilsinger Company Parent, LLC | 1 |
| MyRx Visual Acuity | 6 Over 6 Vision Ltd | 1 |
| M&S Technologies Smart System® 20/20 Tablet | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies Smart System® PC-Plus | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies Clinical Trial Suite® | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies Melbourne Rapid Fields Device In-Clinic | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies Smart System® Virtual Reality Headset System | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies Smart System® Standard | The Hilsinger Company Parent, LLC | 1 |
Showing 12 of 14. All products under Digital Visual Acuity Test
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.