Data / Medical devices / Switzerland / This AG
This AG: FDA-registered device maker in Heerbrugg Sankt Gallen, Switzerland, 1 510(k) clearance
This AG is registered with the FDA (registration 3042928348) in Heerbrugg Sankt Gallen, Switzerland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3042928348
- Address
- Widnauerstrasse 1, Heerbrugg Sankt Gallen, Switzerland, 9435
- Owner or operator
- This AG (10094659)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 15, 2025
- Registered through
- 2026
- Brand names listed
- Sophi
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| November 14, 2025 | K250501 | System Sophi | HQC | Substantially Equivalent | This AG | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- All makers of Unit, Phacofragmentation
Updated November 14, 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.