Koroad America
Country not established
- Devices
- 1
What Koroad America makes
Koroad America manufactures the Alpha Pure, a Class II medical device designed for sterile wound irrigation and debridement in clinical settings.
The Alpha Pure is regulated under the FDA’s 510(k) pathway as a Class II device and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Alpha Pure Ref K163117
510(k) 510(k)
Frequently asked questions
How many devices does Koroad America have in the registry?
The registry currently lists 1 device for Koroad America. Devices recorded under merged duplicate company entries are counted once.
Which registries list Koroad America's devices?
Among its 1 most recently registered device, Koroad America has devices listed in FDA 510(k) (1 device).
What risk classes do Koroad America's devices fall under?
Among its 1 most recently registered device, the classes recorded for Koroad America's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Koroad America in the registry?
The most recently registered devices listed for Koroad America include Alpha Pure.