Ri-Vision With Slit Retinoscope XL/LED 3,5V/120V,
Catalogue number 3796-203, listed by Rudolf Riester Gmbh, Germany, under Retinoscope, Battery-Powered. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Rudolf Riester Gmbh, Germany |
|---|---|
| FDA product code | HKM |
| Device type | Retinoscope, Battery-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1780 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K964338 |
| Record published | 2021-01-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3796-203 | 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 LED Retinoscope | Heine Optotechnik Gmbh & Co. KG. | 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K964338 | 1997-01-09 |
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.