This AG
SwitzerlandFDA applicant, unverified FDA FEI 3042928348
- Devices
- 16
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What This AG makes
This manufacturer produces the System Sophi, a medical device designed for [specific clinical application not provided in data]. The system is intended for [purpose not detailed, but implied as a Class II device, e.g., diagnostic, monitoring, or therapeutic use in a defined medical context].
The System Sophi is classified as a Class II device under US regulations and has been authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Search and filter all 16 devicesCompany details
- FDA FEI number
- 3042928348
- DUNS number
- 480032801
- Address
- Widnauerstrasse 1, Heerbrugg Sankt Gallen
- [email protected]
- Phone
- +41715440870
Frequently asked questions
How many devices does This AG have in the registry?
The registry currently lists 16 devices for This AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list This AG's devices?
Among its 16 most recently registered devices, This AG has devices listed in FDA 510(k) (1 device) and FDA GUDID (15 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do This AG's devices fall under?
Among its 16 most recently registered devices, the classes recorded for This AG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from This AG in the registry?
The most recently registered devices listed for This AG include SOPHI 1401-0100-ACW, SOPHI 1401-0100-A, SOPHI A 1801-0100 and Cassette Peristaltic Sophi 1401-5200.