Manufacturer registered with FDA
ChangShu Beyond Medical Device Co., Ltd.
Changshu, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 728 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name ChangShu Beyond Medical Device Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | ChangShu Beyond Medical Device Co., Ltd. | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | CHANGSHU BEYOND MEDICAL DEVICE CO., LTDCHANGSHU BEYOND MEDICAL DEVICE CO. LTD, · CHANGSHU BEYOND MEDICAL DEVICE CO,.LTD | 11 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | ChangShu Beyond Medical Device Co., Ltd | 8 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CHANGSHU BEYOND MEDICAL DEVICE Co. Ltd. | 3 | 2016–2022 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Changshu Beyond Medical Device CO., LTD | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ChangShu Beyond Medical Device Co., Ltd. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Changshu Beyond Medical Device Co., ltd.Changshu Beyond Medical Device Co.,Ltd. | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What ChangShu Beyond Medical Device Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | beyondwound drainage reservoir | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CHANGSHU BEYOND MEDICAL DEVICE CO., LTD.FDA reg. 3010806410 | Changshu Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046360). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.