Manufacturer and brand owner in Beijing, China. 2 device types, 2 products catalogued, 1 clearance.
Keya Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Automated Radiological Image Processing Software, Coronary Vascular Physiologic Simulation Software. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
Registration
FDA registration record for Keya Medical Technology Co., Ltd. | Registered name | KEYA MEDICAL TECHNOLOGY CO.,LTD. |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3025430791 |
| FEI number | 3025430791 |
| DUNS | 551093357 |
| Establishment type | Manufacturer |
Chinese Registration
Chinese company register details for Keya Medical Technology Co., Ltd. | Chinese legal name | 科亚医疗科技股份有限公司 |
| Unified social credit code | 91110107MA003FAC67 |
| Source | NMPA UDI database |
Location
Address of Keya Medical Technology Co., Ltd. | City | Beijing |
| Province | Beijing |
| Address | No.1502-1, 1502-2, 1502-3, Floor 15, Building 1, Yard No.1, Ronghua South Road,Beijing Economic-Technological |
| Postal code | 100176 |
| Country | China |
Clearances
1 clearance names Keya Medical Technology Co., Ltd. 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 Keya Medical Technology Co., Ltd. | Founded | 2016 |
| Employees | 100+ |
| Main products | AI coronary artery diagnostic system, Pulmonary intelligent diagnostic system, Neurological imaging analysis, Cardiac analysis software |
| Certifications | NMPA AI Class III |
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.