Data / Medical devices / United Kingdom / Suntech Uk Limited
Suntech Uk Limited: FDA-registered device maker in Reigate Surrey, United Kingdom, 2 510(k) clearances
Suntech Uk Limited is registered with the FDA (registration 3020640553) in Reigate Surrey, United Kingdom. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020640553
- Address
- Unit H. The Courtyard Business Centre, Dovers Farm, Lonesome Lane, Reigate Surrey, United Kingdom, RH2 7QT
- Owner or operator
- SunTech Uk Limited (10087475)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- March 3, 2023
- Registered through
- 2026
- Brand names listed
- eFOLDi Navigator Powerchair STPC-A, eFOLDi Scooter, Lite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 8, 2025 | K243110 | eFOLDi Navigator Powerchair (STPC-A) | ITI | Substantially Equivalent | Suntech UK , Ltd. | accessdata.fda.gov |
| February 22, 2023 | K223492 | eFOLDi Scooter, Lite | INI | Substantially Equivalent | Suntech UK , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 8, 2025. 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.