OUR United Corporation
Manufacturer and brand owner in Xian, Shaanxi, China. 2 device types, 2 products catalogued, 3 clearances.
OUR United Corporation is a contract manufacturer holding a current FDA establishment registration. The registration covers Accelerator, Linear, Medical, System, Radiation Therapy, Radionuclide. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
2device types registered with the FDA
2products catalogued under its own name
3510(k) clearances
Registration
| Registered name | OUR UNITED CORPORATION |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015620182 |
| FEI number | 3015620182 |
| DUNS | 560458511 |
| Establishment type | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 西安大医集团股份有限公司 |
|---|---|
| Unified social credit code | 91610132566032976D |
| Source | NMPA UDI database |
Location
| City | Xian |
|---|---|
| Province | Shaanxi |
| Address | Room 10301, 3rd Floor, Unit 1, Block 28, Shou Chuang International Business Center, NO. 66 Fengcheng 12 Road |
| Postal code | 710018 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accelerator, Linear, Medical | Class 2 | TaiChiA, Gemini360RT X/Gamma Ray Integrated Digital Radiotherapy System | 2023 | 8 |
| System, Radiation Therapy, Radionuclide | Class 2 | CybeRay, Gemini360RT X/Gamma Ray Integrated Digital Radiotherapy System | 2023 | 3 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210921 | 2021-11-02 | IYE | Traditional | This company |
| K203250 | 2021-03-12 | IWB | Traditional | This company |
| K193207 | 2020-08-07 | IYE | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Xian Airfoil Technology Co., Ltd. | 8 |
| Xian Kaydee Medical Appliances Co., Ltd. | 2 |
| Xi’an Taibo Laser Beauty Company | 1 |
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.