Manufacturer registered with FDA
Shanghai Wonderful Opto Electrics Tech Co Ltd
Shanghai, 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
- 610 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Shanghai Wonderful Opto Electrics Tech 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 Wonderful Opto Electrics Tech Co Ltd | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Shanghai Wonderful Opto-Electrics Tech. Co., LtdShanghai Wonderful Opto-Electrics Tech. Co., Ltd. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHANGHAI WONDERFUL OPTO-ELECTRICS TECH CO., LTD | 2 | 2023–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. | 2 | 2010–2011 | Pure Global AI |
| Australia | TGA | Manufacturer | Shanghai Wonderful Opto Electrics Tech Co Ltd | 1 | 2025–2025 | 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 Wonderful Opto Electrics Tech 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 | Diode Laser System | 2024 |
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 WONDERFUL OPTO-ELECTRICS TECH. CO., LTDFDA reg. 3004505220 | Shanghai, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044427). 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.