Manufacturer registered with FDA
Shanghai EA Medical Instruments Co., Ltd.
Shanghai, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 12023–2023
- Markets registered in
- 717 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Shanghai EA Medical Instruments 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 EA Medical Instruments Co., Ltd. | 1 clearances | 2023–2023 | Below |
| European Union | EUDAMED | Registration holder | Shanghai EA Medical Instruments Co., Ltd. | 9 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Shanghai EA Medical Instruments Co Ltd | 3 | 2026–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Shanghai EA Medical Instruments Co., Ltd. | 2 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHANGHAI EA MEDICAL INSTRUMENTS CO., LTD. | 1 | 2024–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Shanghai EA Medical Instruments Co., Ltd. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shanghai EA Medical Instruments 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 Shanghai EA Medical Instruments 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 |
|---|---|---|---|---|
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | — | 2023 |
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 EA MEDICAL INSTRUMENTS CO., LTD.FDA reg. 3016730274 | Yangpu District Shanghai, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089566). 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.