Elbio Co., Ltd.
Country not established
- Devices
- 1
What Elbio Co., Ltd. makes
Elbio Co., Ltd. manufactures the COOLSKIN device, which is classified as a Class II medical device.
The company is based in the US and the COOLSKIN device is listed in the FDA 510(k) registry.
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Coolskin Ref K083008
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Elbio Co., Ltd. have in the registry?
The registry currently lists 1 device for Elbio Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elbio Co., Ltd.'s devices?
Among its 1 most recently registered device, Elbio Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Elbio Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Elbio Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elbio Co., Ltd. in the registry?
The most recently registered devices listed for Elbio Co., Ltd. include COOLSKIN.