Mali, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Mali, Inc. makes
Mali, Inc. manufactures male external catheters designed for urinary drainage, including a near-infrared (NIR) light-assisted model for improved positioning and a catheter with a textured surface to enhance patient comfort.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. Their portfolio is listed in the FDA’s 510(k) database, and the company is headquartered in the United States.
Catalogue
Nir Lat Male External Catheter Ref K855209
Regimes: 510(k) Registry: 510(k)Gentle Feel Ref K864176
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mali, Inc. have in the registry?
The registry currently lists 2 devices for Mali, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mali, Inc.'s devices?
Among its 2 most recently registered devices, Mali, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Mali, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mali, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mali, Inc. in the registry?
The most recently registered devices listed for Mali, Inc. include NIR LAT MALE EXTERNAL CATHETER and GENTLE FEEL.