Glimex Corp.
Country not established
- Devices
- 1
What Glimex Corp. makes
Glimex Corp. manufactures the OASIS, a medical device designed for [specific clinical purpose or function—if unspecified, omit or clarify as 'a Class II device for [general category, e.g., patient monitoring, diagnostic imaging, or procedural support]'].
The OASIS is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Oasis Ref K984218
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Glimex Corp. have in the registry?
The registry currently lists 1 device for Glimex Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Glimex Corp.'s devices?
Among its 1 most recently registered device, Glimex Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Glimex Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Glimex Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Glimex Corp. in the registry?
The most recently registered devices listed for Glimex Corp. include OASIS.