Manufacturer registered with FDA
Hefei Meyer Optoelectronic Technology Inc.
Hefei, China. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 12026–2026
- Markets registered in
- 719 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Hefei Meyer Optoelectronic Technology Inc. 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 | Hefei Meyer Optoelectronic Technology Inc. | 1 clearances | 2026–2026 | Below |
| European Union | EUDAMED | Manufacturer | Hefei Meyer Optoelectronic Technology Inc. | 7 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hefei Meyer Optoelectronic Technology Inc. | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HEFEI MEYER OPTOELECTRONIC TECHNOLOGY INC. | 3 | 2023–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Hefei Meyer Optoelectronic Technology Inc | 2 | 2020–2020 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | HEFEI MEYER OPTOELECTRONIC TECHNOLOGY INC | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Hefei Meyer Optoelectronic Technology Inc. | 1 | 2024–2024 | 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 Hefei Meyer Optoelectronic Technology Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Intraoral Scanner | 2024 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | Dental Cone-beam Computed Tomography (mDX-15P Series) | 2026 |
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 |
|---|---|---|
| HEFEI MEYER OPTOELECTRONIC TECHNOLOGY INC.FDA reg. 3013510497 | Hefei Anhui, China | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089944). 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.