Bernell
Confirmation Bar with +0.50 | +0.25 | -0.25 | -0.50
4manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Bernell |
|---|---|
| FDA product code | HMH |
| Device type | Rack, Skiascopic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1750 |
| Premarket notification | Exempt |
| Record published | 2026-05-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSLRS8 | In distribution | |
| CBAR4 | In distribution | |
| L122084 | In distribution | |
| TOM180 | In distribution | |
| HTLRPS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 2 |
| Visionix | Luneau Technology Operations | 1 |
| Retinoscopy Rack | Gulden Ophthalmics | 1 |
| Retinoscopy Rack with Compass | Gulden Ophthalmics | 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.