Manufacturer registered with FDA
ARI Medical Technology Co., Ltd.
Hefei, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 324 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name ARI Medical 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 | ARI Medical Technology Co., Ltd. | 2 device types | — | Below |
| Tanzania | TMDA | Manufacturer | ARI MEDICAL TECHNOLOGY CO., LIMITEDARI MEDICAL TECHNOLOGY CO., LTD. · ARI Medical Technology Co. Ltd · +2 | 14 | 2023–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ARI MEDICAL TECHNOLOGY CO., LTD. | 10 | — | 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 ARI Medical 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 |
|---|---|---|---|---|
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | ARI Medical Suction Unit | 2023 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | ARI Medical Dental Unit, Dental Chair, Dental Scanner, Dental Accessorie+D7:D8s | 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 |
|---|---|---|
| ARI MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3024082778 | Hefei Anhui, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088962). 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.