Data / Medical devices / China / Hefei Meyer Optoelectronic Technology Inc.
Hefei Meyer Optoelectronic Technology Inc.: FDA-registered device maker in Hefei Anhui, China, 1 510(k) clearance
Hefei Meyer Optoelectronic Technology Inc. is registered with the FDA (registration 3013510497) in Hefei Anhui, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013510497
- Address
- No.668 Wangjiang West Road, High and New Tech, Industry Development Zone, Hefei Anhui, China, 230088
- Owner or operator
- Hefei Meyer Optoelectronic Technology Inc. (10089944)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 7, 2024
- Registered through
- 2026
- Brand names listed
- Dental Cone-beam Computed Tomography (mDX-15P Series), Intraoral Scanner
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 23, 2026 | K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) | OAS | Substantially Equivalent | Hefei Meyer Optoelectronic Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of X-Ray, Tomography, Computed, Dental
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Updated July 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.