Sisu Global Health
Country not established
- Devices
- 1
What Sisu Global Health makes
Sisu Global Health manufactures the HemaFuse System, a medical device designed for the rapid separation of blood components, including plasma and red blood cells, during transfusion procedures.
The HemaFuse System is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Hemafuse System Ref K210862
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sisu Global Health have in the registry?
The registry currently lists 1 device for Sisu Global Health. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sisu Global Health's devices?
Among its 1 most recently registered device, Sisu Global Health has devices listed in FDA 510(k) (1 device).
What risk classes do Sisu Global Health's devices fall under?
Among its 1 most recently registered device, the classes recorded for Sisu Global Health's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sisu Global Health in the registry?
The most recently registered devices listed for Sisu Global Health include Hemafuse System.