Manufacturer registered with FDA
AOJ HEALTH Technology Co., Ltd.
Shenzhen, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1039 registrations outside the US
- Establishments
- 1China
Registered in 10 markets
Where regulators' registries name AOJ HEALTH Technology 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 | AOJ HEALTH Technology Co., Ltd. | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | AOJ HEALTH TECHNOLOGY CO., LTD | 12 | 2024–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | AOJ HEALTH Technology Co., Ltd. | 9 | — | Pure Global AI |
| Australia | TGA | Manufacturer | AOJ HEALTH Technology Co Ltd | 8 | 2024–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | AOJ HEALTH TECHNOLOGY CO., LTD. | 2 | 2025–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | AOJ HEALTH TECHNOLOGY CO., LTD | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | AOJ HEALTH Technology Co., Ltd. | 2 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | AOJ HEALTH Technology Co., Ltd. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | AOJ HEALTH Technology Co., Ltd | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | AOJ HEALTH Technology 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 AOJ HEALTH Technology 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 |
|---|---|---|---|---|
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | Ultrasonic Cleaner USC-10Ultrasonic Cleaner USC-20 | 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 |
|---|---|---|
| AOJ HEALTH TECHNOLOGY CO., LTD.FDA reg. 3020994856 | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084496). 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.