Registered with FDA
Shanghai Hua EN Industrial Co. Ltd.
Shanghai, China. Lists 21 dental device types with FDA across 1 registered establishment.
- Device types listed
- 21
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Shanghai Hua EN Industrial 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 | Lister | Shanghai Hua EN Industrial Co. Ltd. | 21 device types | — | Below |
| Brazil | ANVISA | Manufacturer | SHANGHAI HUA EN INDUSTRIAL CO., LTD | 2 | 2023–2023 | 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 Shanghai Hua EN Industrial Co. Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
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 |
|---|---|---|
| Shanghai Hua En Industrial Co LtdFDA reg. 3010147274 | Shanghai, China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043241). 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.