Beijing Ikey Medical Device Technology Co., Ltd.
Registered establishment in Beijing, China. 1 device type.
Beijing Ikey Medical Device Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | BEIJING IKEY MEDICAL DEVICE TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3040391045 |
| FEI number | 3040391045 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 北京科仪邦恩医疗器械科技有限公司 |
|---|---|
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | Floor 1-2, Building 1, 30 Yongchang South Road Beijing, CN 100176 |
| Postal code | 100176 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | iKey Total Knee System, KeYi Total Knee System | 2025 | 21 |
Clearances
No clearance names Beijing Ikey Medical Device Technology Co., Ltd. as applicant. One 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.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230120 | 2024-04-19 | JWH | Traditional | Beijing Keyi Medical Device Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Main products | Orthopedic Implants, Joint Implants, Spine Implants, Trauma Implants |
| Certifications | FDA, CE, ISO, PMDA |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.