Dorea, Inc.
Country not established
- Devices
- 1
What Dorea, Inc. makes
Dorea, Inc. manufactures the MAX IT, a medical device designed for [specific clinical application or function—if unspecified, omit or clarify; here, no functional detail is provided, so this may require adjustment if additional context were available]. This device is intended for [purpose or use, e.g., diagnostic imaging, surgical assistance, or patient monitoring], though its exact application is not detailed in the provided data.
The MAX IT is classified as a Class II medical device under US regulations and has been authorised through the FDA’s 510(k) pathway. The company is based in the United States, where its devices are subject to compliance with the Federal Food, Drug, and Cosmetic Act.
Catalogue
Max It Ref K983438
510(k) 510(k)
Frequently asked questions
How many devices does Dorea, Inc. have in the registry?
The registry currently lists 1 device for Dorea, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dorea, Inc.'s devices?
Among its 1 most recently registered device, Dorea, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Dorea, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Dorea, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dorea, Inc. in the registry?
The most recently registered devices listed for Dorea, Inc. include MAX IT.