Shinsei Corp.
Country not established
- Devices
- 1
What Shinsei Corp. makes
Shinsei Corp. manufactures HEATPAC, a medical device designed for patient warming during surgical procedures or critical care interventions to maintain core body temperature.
The HEATPAC device is classified as Class II under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Heatpac Ref K810320
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Shinsei Corp. have in the registry?
The registry currently lists 1 device for Shinsei Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shinsei Corp.'s devices?
Among its 1 most recently registered device, Shinsei Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Shinsei Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Shinsei Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shinsei Corp. in the registry?
The most recently registered devices listed for Shinsei Corp. include HEATPAC.