Manufacturer registered with FDA
Dragon Medical Co.,Ltd
Suzhou City, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 772 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name Dragon 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 | Dragon Medical Co.,Ltd | 2 device types | — | Below |
| European Union | EUDAMED | Registration holder | Dragon Medical Co.,Ltd | 49 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Dragon Medical Co.,LtdDragon Medical Co., Ltd. · DRAGON MEDICAL CO., LTD · +2 | 8 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | DRAGON MEDICAL CO.,LTDDragon Medical Co., Ltd. | 7 | 2016–2026 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Dragon medical Co.,Ltd | 4 | 2025–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Dragon Medical Co Ltd | 3 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DRAGON MEDICAL CO.,LTD | 1 | 2021–2021 | 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 Dragon 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 |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Teeth Whitening | 2019 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric Toothbrush, Replaceable Toothbrush Head, Toothbrush Head, Replacement Head | 2019 |
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 |
|---|---|---|
| Dragon Medical Co.,LtdFDA reg. 3013524663 | Suzhou City Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054765). 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.