Labomed eVO300 5-Step Slit Lamp -Halogen (HL)
Catalogue number 8126200, listed by Labotech Microscopes India Private Limited, India, under Biomicroscope, Slit-Lamp, Ac-Powered, Exempt. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
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 | Labotech Microscopes India Private Limited, India |
|---|---|
| FDA product code | PUE |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-17 |
| Record revised | 2025-09-29 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-09-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8126200 | Withdrawn |
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 |
| Moptim | Shenzhen Certainn Technology Co., Ltd. | 1 |
| RM03 | Haag-Streit AG | 1 |
| Labomed eVO350 5-Step Slit lamp -LED | Labotech Microscopes India Private Limited | 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.