Beta 200 LED Retinoscope
3,5 V
8manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (1), Shaanxi (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 |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| 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 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Shanghai Supore Instruments Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Heine Optotechnik Gmbh & Co. KG., Germany |
|---|---|
| FDA product code | HKM |
| Device type | Retinoscope, Battery-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1780 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-12 |
| Record revised | 2024-07-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Packaging | Carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000 | In distribution | |
| 2,5 V | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| zumax | Zumax Medical Co., Ltd. | 20 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 13 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 2 |
| ri-scope® retinoscope head slit XL 3.5 V | Rudolf Riester Gmbh | 2 |
| Beta 200 Retinoscope | Heine Optotechnik Gmbh & Co. KG. | 2 |
| ri-vision with slit retinoscope XL/LED 3,5V, C han | Rudolf Riester Gmbh | 2 |
| ri-vision with retinoscope slit XL 3.5 V, C-handle | Rudolf Riester Gmbh | 1 |
| ri-vision with slit retinoscope XL/LED 3,5V/120V, | Rudolf Riester Gmbh | 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.