Manufacturer registered with FDA
Jiangsu JianYu Health Medical Co., Ltd
Changzhou City, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 936 registrations outside the US
- Establishments
- 1China
Registered in 9 markets
Where regulators' registries name Jiangsu JianYu Health Medical 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 | Jiangsu JianYu Health Medical Co., Ltd | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Jiangsu JianYu Health Medical Co., Ltd. | 12 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Jiangsu Jianyu Health Medical Co., Ltd. | 11 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Jiangsu JianYu Health Medical Co., Ltd. | 4 | 2022–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Jiangsu Jianyu Health Medical Co Ltd | 3 | 2020–2020 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | JIANGSU JIANYU HEALTH MEDICAL CO. LTDJIANGSU JIANYU HEALTH MEDICAL CO., LTD | 2 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Jiangsu JianYu Health Medical Co Ltd | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JIANGSU JIANYU HEALTH MEDICAL CO., LTD. | 1 | 2023–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Jiangsu JianYu Health Medical Co.ltd | 1 | — | 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 Jiangsu JianYu Health Medical 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 |
|---|---|---|---|---|
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophylaxis Cup | 2011 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Resin Applicator | 2011 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | Oral Care Kits | 2024 |
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 |
|---|---|---|
| Jiangsu JianYu Health Medical Co., LtdFDA reg. 3014926389 | Changzhou City Jiangsu, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10039161). 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.