Galloway Technologies, LLC
Country not established
- Devices
- 1
What Galloway Technologies, LLC makes
Galloway Technologies, LLC manufactures the ASYRA, a portable, non-invasive diagnostic device designed for rapid blood analysis, including measurements of glucose, lactate, and other biomarkers. The device is intended for point-of-care use in clinical and pre-hospital settings, providing real-time patient monitoring without traditional lab processing.
The ASYRA is classified as a Class II medical device in the U.S. and has been cleared via the FDA’s 510(k) pathway. The company is based in the United States, and its product is registered under the relevant U.S. regulatory requirements.
Catalogue
Asyra Ref K023355
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Galloway Technologies, LLC have in the registry?
The registry currently lists 1 device for Galloway Technologies, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Galloway Technologies, LLC's devices?
Among its 1 most recently registered device, Galloway Technologies, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Galloway Technologies, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Galloway Technologies, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Galloway Technologies, LLC in the registry?
The most recently registered devices listed for Galloway Technologies, LLC include ASYRA.