Manufacturer and brand owner in Wuhan, Hubei, China. 1 device type, 2 products catalogued.
OUR SMD Medical (Wuhan) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers System, Radiation Therapy, Radionuclide. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
Registration
FDA registration record for OUR SMD Medical (Wuhan) Co., Ltd. | Registered name | OUR SMD MEDICAL (WUHAN) CO., LTD. |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3020999824 |
| FEI number | 3020999824 |
| DUNS | 530271160 |
| Establishment type | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
Chinese Registration
Chinese company register details for OUR SMD Medical (Wuhan) Co., Ltd. | Chinese legal name | 武汉数码刀医疗有限公司 |
| Unified social credit code | 914201157924319327 |
| Source | NMPA UDI database |
Location
Address of OUR SMD Medical (Wuhan) Co., Ltd. | City | Wuhan |
| Province | Hubei |
| Address | No. 1, 2, 3 & 4, F1, Block B21, High-tech Medical Devices Park, No.818 Gaoxin Ave., |
| Postal code | 430223 |
| Country | China |
Clearances
No clearance names OUR SMD Medical (Wuhan) Co., Ltd. as applicant. 2 are 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.
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.