Manufacturer registered with FDA
E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.
Hangzhou, 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
- 38 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name E.M.S. Electro Medical Systems (Hangzhou) 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 | E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd. | 1 device types | — | Below |
| Australia | TGA | Manufacturer | EMS Electro Medical Systems (Hangzhou) Co Ltd | 7 | 2014–2022 | Pure Global AI |
| South Korea | MFDS | Manufacturer | E.M.S. Electro Medical Systems(Hangzhou) Co., Ltd. | 1 | 2026–2026 | 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 E.M.S. Electro Medical Systems (Hangzhou) 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 |
|---|---|---|---|---|
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Maker | Dental Amalgamator; VOCO GIC Mixer | 2017 |
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 |
|---|---|---|
| E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.FDA reg. 3008530360 | Hangzhou Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055959). 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.