Data / Medical devices / United Kingdom / Tristel Solution Ltd
Tristel Solution Ltd: FDA-registered device maker in Snailwell Cambridgeshire, United Kingdom, 2 510(k) clearances
Tristel Solution Ltd is registered with the FDA (registration 3006892175) in Snailwell Cambridgeshire, United Kingdom. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006892175
- Address
- Unit 1b, Lynx Business Park Fordham Road, Snailwell Cambridgeshire, United Kingdom, CB8 7NY
- Owner or operator
- Tristel Solution Ltd (10088469)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 9, 2023
- Registered through
- 2026
- Brand names listed
- Tristel OPH, Tristel ULT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Foam Or Gel Chemical Sterilant/High Level Disinfectant | QWS | 2 | Manufacturer, 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 9, 2025 | K242732 | Tristel OPH | QWS | Substantially Equivalent | Tristel Solutions , Ltd. | accessdata.fda.gov |
| June 2, 2023 | DEN220041 | Tristel Duo ULT | QWS | Unknown | Tristel Solutions Limited | accessdata.fda.gov |
Updated May 9, 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.