Mediworks
Operation microscope used for observation of surgical and other medical procedures,consisting of an optical system of observation,including objective lens,variable or fixed power optical…
Operation microscope used for observation of surgical and other medical procedures,consisting of an optical system of observation,including objective lens,variable or fixed power optical system,observation tube and eyepieces.
Who Else Makes It
Concentrated in Jiangsu (5), Guangxi (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Shenzhen Certainn Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Suzhou Raish Meditech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Shanghai Mediworks Precision Instruments Co., Ltd., China |
|---|---|
| FDA product code | HRM |
| Device type | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-02 |
| Record revised | 2022-12-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SM621 | In distribution | |
| SM620 | In distribution | |
| SM610 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Inami | Inami & Co., Ltd. | 9 |
| Luxor | Alcon Laboratories, Inc. | 8 |
| Unbranded | Advance Medical Designs, Inc. | 8 |
| Procam HD 2D | Ecleris SRL | 5 |
| Unity | Alcon Laboratories, Inc. | 4 |
| Dovetail for Biom | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 4 |
| Inverter Vitrectomy System Set For Leica Type Microscopes | Ocular Instruments, Inc. | 4 |
| Optomic | Optomic España SA | 3 |
| Moptim | Shenzhen Certainn Technology Co., Ltd. | 3 |
| LuxOR Revalia | Alcon Laboratories, Inc. | 3 |
| Microscope Cover Leica 137/380 7.00 HLT | Pharma Sept Medical Products (1995) Ltd. | 3 |
| Inverter Vitrectomy System Set For Zeiss Type Microscopes | Ocular Instruments, Inc. | 3 |
Showing 12 of 152. All products under Microscope, Operating & Accessories, Ac-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.