Hisense
Catalogue number HME8C27, listed by Qingdao Hisense Medical Equipment Co., Ltd., China, under Camera, Television, Surgical, Without Audio. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Nanjing Jusha Display Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
| Qingdao Hisense Medical Equipment Co., Ltd. | Qingdao | Shandong | Manufacturer | 5 |
| LG Electronics Nanjing New Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 4 |
| Arthrex Medical Device (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 3 |
Record
| Listed by | Qingdao Hisense Medical Equipment Co., Ltd., China |
|---|---|
| FDA product code | FWB |
| Device type | Camera, Television, Surgical, Without Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-11 |
| Record revised | 2024-05-03 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HME8C27 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LG | LG Electronics Inc. | 25 |
| Stryker | Barco, Inc | 5 |
| VisionPro | Stryker GmbH | 1 |
| Visionflex | Visionflex PTY Limited | 1 |
| Arthrex | LG Electronics Inc. | 1 |
| 32″ 4K OLED Surgical Display | Stryker GmbH | 1 |
| MTS | Medicapture, Inc. | 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.