Ophthalmic Unit
A mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer,…
A mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient’s eyes. It has powered height adjustments enabling the clinician to raise/lower the surface, or seated patient, to align the instruments to the patient’s eye level. Some designs may incorporate the patient chair as part of the unit and even facilitate easy swinging aside mechanisms to accommodate wheelchair bound patients. Controls may enable the adjustment of peripheral devices within the examination room.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Beijing (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 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 12 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
| Langfang FAR East Prosperous Optical Instrument Co., Ltd. | Langfang | Hebei | Contract manufacturer | 5 |
Record
| Listed by | Ningbo Ming Sing Optical R&D Co., Ltd., China |
|---|---|
| FDA product code | HRJ |
| Device type | Table, Instrument, Powered, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4855 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TCS-820 | In distribution | |
| TCS-900 | In distribution | |
| TCS-880 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ophthalmic Electric Table | MDT SP. Z O.O. | 20 |
| S4 Optik | Innova Medical Ophthalmics | 7 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 6 |
| Ellex | Ellex Medical Pty Ltd | 5 |
| IDS-300 | Topcon Corp. | 4 |
| Motorized Instrument Table | Lightmed Corp. | 3 |
| AIT-250W | Topcon Corp. | 3 |
| System Table | Nidek Incorporated | 3 |
| Evans (Instruments) Limited | Evans (Instruments) Limited | 2 |
| AIT-16A | Topcon Corp. | 2 |
| AIT-350W | Topcon Corp. | 2 |
| S4Optik | Innova Medical Ophthalmics | 2 |
Showing 12 of 54. All products under Table, Instrument, Powered, Ophthalmic
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.