Data / Medical devices / China / Sinovation (Beijing) Medical Technology Co., Ltd
Sinovation (Beijing) Medical Technology Co., Ltd: FDA-registered device maker in Beijing, China, 1 510(k) clearance
Sinovation (Beijing) Medical Technology Co., Ltd is registered with the FDA (registration 3027616024) in Beijing, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 18, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027616024
- Address
- Building 6, No. 69, Qingfeng West Road, Daxing District, Beijing, China, 102600
- Owner or operator
- Sinovation (Beijing) Medical Technology Co., Ltd (10088361)
- Roles
- Manufacturer
- First device listed
- July 14, 2023
- Registered through
- 2027
- Brand names listed
- Alpha Omega AXON, Sinobot X1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2023 | K220072 | Sinobot X1 | HAW | Substantially Equivalent | Sinovation (Beijing) Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 18, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.