Manufacturer registered with FDA
Jiangxi AICARE Medical Technology Co., Ltd
Fuzhou, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 524 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Jiangxi AICARE Medical Technology 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 | Jiangxi AICARE Medical Technology Co., Ltd | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Jiangxi Aicare Medical Technology Co.,Ltd | 19 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Jiangxi AICARE Medical Technology Co., Ltd. | 3 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Jiangxi AICARE Medical Technology Co., Ltd. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | JIANGXI AICARE MEDICAL TECHNOLOGY Co, Ltd. | 1 | 2020–2020 | 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 Jiangxi AICARE Medical Technology 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Oral irrigatorWT101,WT102,WT103,WT105,WT106,WT107,WT108 | 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 |
|---|---|---|
| JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTDFDA reg. 3016630774 | Fuzhou Jiangxi, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10065465). 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.