Bionix Radiation Therapy
2.4MM 10X10, Standard U-Frame
22manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (10), Jiangsu (5), Shanghai (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Jiujiang Huada Medical Dressing Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 18 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 7 |
| Fengtai County Guqiao Town Changxing Shoe Factory | Huainan | Anhui | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
Showing 12 of 22. All 22 manufacturers in China registered for Component, Cast
Record
| Listed by | Bionix Radiation Therapy, LLC |
|---|---|
| FDA product code | LGF |
| Device type | Component, Cast |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5940 |
| Record published | 2017-04-25 |
| Record revised | 2023-07-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Box of 10 |
| Distribution end date | 2020-10-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EMRT-8300 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tex-Care Medical | Flynt Amtex, Inc. | 16 |
| CastWedge™ | Position Health, LLC | 5 |
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.