Data / Medical devices / China / Sino Canada Health Engineering Research Institute (hefei) Ltd. (scheri)
Sino Canada Health Engineering Research Institute (hefei) Ltd. (scheri): FDA-registered device maker in Hefei Anhui, China, 1 510(k) clearance
Sino Canada Health Engineering Research Institute (hefei) Ltd. (scheri) is registered with the FDA (registration 3027325776) in Hefei Anhui, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027325776
- Address
- Building B5 National Health Big Data Industrial Park Intersection of Xiyou Road and Kongquetai Road, High-tech Zone, Hefei Anhui, China, 230088
- Owner or operator
- Sino Canada Health Engineering Research Institute (Hefei) Lt (10086903)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 22, 2023
- Registered through
- 2026
- Brand names listed
- MOBINEURO Alita Intraoperative MRI System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 20, 2023 | K223875 | MOBINEURO Alita Intraoperative MRI System | LNH | Substantially Equivalent | Sino Canada Health Engineering Research Institute (Hefei) | accessdata.fda.gov |
Compare with other makers
Updated March 20, 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.