Sandbox Ent.
Country not established
- Devices
- 1
What Sandbox Ent. makes
Sandbox Ent. manufactures Sandbox I, Sandbox II, and Sandbox Jr., which appear to be Class II medical devices. These products are likely intended for specific clinical applications requiring regulatory oversight, though exact uses are not specified.
The company’s portfolio is regulated under U.S. FDA 510(k) clearance as Class II devices. These devices are listed in the FDA’s 510(k) database, indicating compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Sandbox I, Sandbox Ii, Sandbox Jr. Ref K903321
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sandbox Ent. have in the registry?
The registry currently lists 1 device for Sandbox Ent.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sandbox Ent.'s devices?
Among its 1 most recently registered device, Sandbox Ent. has devices listed in FDA 510(k) (1 device).
What risk classes do Sandbox Ent.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sandbox Ent.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sandbox Ent. in the registry?
The most recently registered devices listed for Sandbox Ent. include SANDBOX I, SANDBOX II, SANDBOX JR..