Moptim
The Slit Lamp comprises an illumination and a Binocular Microscope. The entire device can be moved in front of the eye using the instrument base. The illumination offers a range of setting…
The Slit Lamp comprises an illumination and a Binocular Microscope. The entire device can be moved in front of the eye using the instrument base. The illumination offers a range of setting possibilities for making the practically invisible areas of the eye visible. There is also a range of accessories available for the Slit Lamp to allow special diagnosis possibilities in addition to the general examinations. A camera may be attached to the slit lamp to take photographs of different parts of the eye.
Who Else Makes It
Concentrated in Jiangsu (5), Chongqing (3), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
| Shenzhen Certainn Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Main Meditech Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
| Chongqing SS Medical Equipments Co., Ltd. | Chongqing | Chongqing | Manufacturer | 3 |
| Shanghai Bolan Optical Electric Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
| Gaush Neotech Ltd. | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Shenzhen Certainn Technology Co., Ltd., China |
|---|---|
| FDA product code | PUE |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2022-12-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Storage environment temperature -10 to 55 °C; Handling environment humidity 30 to 90 % RH; Handling environment atmospheric pressure 80 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SL-M6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ophthalmic Slit Lamp Microscope | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 20 |
| Headrest | Haag-Streit AG | 16 |
| Microclear | Suzhou Microclear Medical Instruments Co., Ltd. | 4 |
| SYL | Chongqing SS Medical Equipments Co., Ltd. | 3 |
| Illuminix | Illuminix Industries LLC | 3 |
| CM02 | Haag-Streit AG | 2 |
| Ocular Surface Analyzer | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2 |
| CM04 | Haag-Streit AG | 2 |
| CM03 | Haag-Streit AG | 2 |
| RM03 | Haag-Streit AG | 1 |
| Labomed eVO350 5-Step Slit lamp -LED | Labotech Microscopes India Private Limited | 1 |
| Imaging Set | Haag-Streit AG | 1 |
Showing 12 of 27. All products under Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
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.