Manufacturer and brand owner in Haining, Zhejiang, China. 6 device types, 5 products catalogued, 4 clearances.
iRay Imaging Technology (Haining) Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Collimator, Manual, Radiographic, Unit, X-Ray, Extraoral With Timer and 4 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
Registration
FDA registration record for iRay Imaging Technology (Haining) Limited | Status | Registered |
| Registration expires | 2026 |
| Registration number | 3023546785 |
| FEI number | 3023546785 |
| DUNS | 722762367 |
| Establishment type | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
Location
Address of iRay Imaging Technology (Haining) Limited | City | Haining |
| Province | Zhejiang |
| Address | 2nd floor and 3rd Floor, Building B, No. 2, Caohejing RD., Haining, Jiaxing, 314499 Zhejiang P.R. China |
| Postal code | 314499 |
| Country | China |
Clearances
4 clearances name iRay Imaging Technology (Haining) Limited as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
From the Company
Published by the company on its own website, not by the FDA.
Information published by iRay Imaging Technology (Haining) Limited | Main products | Digital X-ray detectors, High-voltage generators, X-ray tubes, Combination radiation sources, OLED microdisplay backplanes |
| Export markets | Global |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.