Manufacturer registered with FDA
Alliedstar Medical Equipment Co., Ltd.
Ziyang, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 19
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1271 registrations outside the US
- Establishments
- 1China
Registered in 12 markets
Where regulators' registries name Alliedstar 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 | Alliedstar Medical Equipment Co., Ltd. | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | ALLIEDSTAR MEDICAL EQUIPMENT CO., LTD. | 19 | 2023–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Alliedstar Medical Equipment Co., Ltd. | 18 | 2023–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Alliedstar Medical Equipment Co., Ltd. | 7 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Alliedstar Medical Equipment Co Ltd | 6 | 2023–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Alliedstar Medical Equipment Co., Ltd. | 5 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Alliedstar Medical Equipment Co., Ltd. | 5 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ALLIEDSTAR MEDICAL EQUIPMENT Co., Ltd. | 4 | 2023–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Alliedstar Medical Equipment Co., Ltd. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Alliedstar Medical Equipment Co., Ltd. | 2 | 2023–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ALLIEDSTAR MEDICAL EQUIPMENT CO., LTD. | 1 | 2024–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | AlliedStar Medical Equipment 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 Alliedstar 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DIP-3DIP-ADIP-D | 2026 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | AS 100AS 200EAS 260AS 260aDI-1i ScanProK EYEK EYE blue XNeoScan 1000NeoScan 2000 6 moreOwandy iosOwandy ios WirelessS300WSprintRay Foundation Scanner (S300W)ST 200EST 300E | 2021 |
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 |
|---|---|---|
| ALLIEDSTAR MEDICAL EQUIPMENT CO., LTD.FDA reg. 3018994222 | Ziyang Sichuan, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10081371). 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.