Manufacturer registered with FDA
Shanghai Handy Medical Equipment Co., Ltd.
Shanghai, China. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 12022–2022
- Markets registered in
- 814 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Shanghai Handy Medical Equipment 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 | Shanghai Handy Medical Equipment Co., Ltd. | 1 clearances | 2022–2022 | Below |
| European Union | EUDAMED | Manufacturer | Shanghai Handy Medical Equipment Co., Ltd. | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Shanghai Handy Medical Equipment Co Ltd | 3 | 2014–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHANGHAI HANDY MEDICAL EQUIPMENT CO., LTD. | 2 | 2026–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | SHANGHAI HANDY MEDICAL EQUIPMENT CO. LTD | 1 | 2017–2017 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHANGHAI HANDY MEDICAL EQUIPMENT CO., LTD | 1 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Shanghai Handy Medical Equipment Co.,Ltd | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shanghai Handy Medical Equipment Co., Ltd. | 1 | 2013–2013 | 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 Handy Medical Equipment 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 |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | HDR SensorHDR-361HDR-461 | 2022 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | HDI-210, HDI-200A, HDI-220D, HDI-220DA, HDI-712C. HDI-712DIntraroral Camera | 2020 |
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 HANDY MEDICAL EQUIPMENT CO., LTD.FDA reg. 3013039893 | Shanghai, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054306). 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.