UnivLabs
Camera is intended for surgical/operative procedures.
6manufacturers in China registered for this device type
1catalogue number
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 | Univlabs Technologies Private Limited, India |
|---|---|
| FDA product code | FWL |
| Device type | Camera, Cine, Endoscopic, Without Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Premarket notification | Exempt |
| Record published | 2025-07-01 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2025-07-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UL3Chip-4K | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accu-Beam | Transamerican Technologies International | 10 |
| Hayden Medical | Hayden Medical Inc | 4 |
| mytaMed | Mytamed, Inc. | 4 |
| Duroscope | FMD. Co., Ltd. | 3 |
| Firefly | Firefly Global | 2 |
| ITS Model-L6K | Inthesmart Co., Ltd. | 1 |
| Prosidio | Prosidio LLC | 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.