Koregon Enterprise, Inc.
Country not established
- Devices
- 1
What Koregon Enterprise, Inc. makes
Koregon Enterprise, Inc. manufactures the HEMO-ALERT, a device designed for monitoring and detecting hemolysis in extracorporeal blood circuits, such as those used in hemodialysis and related therapies.
The HEMO-ALERT is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Hemo-Alert Ref K893830
510(k) 510(k)
Frequently asked questions
How many devices does Koregon Enterprise, Inc. have in the registry?
The registry currently lists 1 device for Koregon Enterprise, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Koregon Enterprise, Inc.'s devices?
Among its 1 most recently registered device, Koregon Enterprise, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Koregon Enterprise, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Koregon Enterprise, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Koregon Enterprise, Inc. in the registry?
The most recently registered devices listed for Koregon Enterprise, Inc. include HEMO-ALERT.