Duroscope
Camera control and light source
6manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Anhui (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Fanxing Guangdian Medical Treatment Equipment Co Ltd | Beijing | Beijing | Contract manufacturer | 5 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Tonglu Youshi Medical Instrument Co., Ltd. | Tonglu | Zhejiang | Manufacturer | 10 |
| Xuzhou Hengjia Electronic Technology Co., Ltd. | Xuzhou | Jiangsu | Manufacturer | 2 |
| Shenzhen Tuyou Medical Imaging Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Xuzhou AKX Electronic Science and Technology Co., Ltd. | Xuzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | FMD. Co., Ltd., Japan |
|---|---|
| FDA product code | FWL |
| Device type | Camera, Cine, Endoscopic, Without Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-02-09 |
| Record revised | 2020-04-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HD-101 | In distribution | |
| UHD-631 | In distribution | |
| CL 150 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accu-Beam | Transamerican Technologies International | 10 |
| Hayden Medical | Hayden Medical Inc | 4 |
| mytaMed | Mytamed, Inc. | 4 |
| Firefly | Firefly Global | 2 |
| ITS Model-L6K | Inthesmart Co., Ltd. | 1 |
| Prosidio | Prosidio LLC | 1 |
| UnivLabs | Univlabs Technologies Private Limited | 1 |
| Health Support | Carolon Co. | 1 |
| ITS Model-L | Inthesmart Co., Ltd. | 1 |
| Redfin | Firefly Global | 1 |
| FocESS | Stryker GmbH | 1 |
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.