Digital Medical Scope
DS-10A is a digital hand-held anterior scope used to record digital photographs and video of anterior area of the human eye and surrounding area.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), Hubei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Hubei Qifu Protective Products Co., Ltd. | Xiantao | Hubei | Manufacturer | 9 |
Record
| Listed by | Nidek Incorporated, United States |
|---|---|
| FDA product code | FXF |
| Device type | Speculum, Illuminated |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-27 |
| Record revised | 2026-04-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2025-12-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DS-10A | Withdrawn | |
| DS-10G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EZY Dose Kids | Apothecary Products, LLC. | 1 |
| Inka | The Trustee for Kaiser Family Trust | 1 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 1 |
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.