Mathis-Koolpe, Inc.
Country not established
- Devices
- 1
What Mathis-Koolpe, Inc. makes
Mathis-Koolpe, Inc. manufactures the BE-SAFE, a medical device designed for [specific function or application not detailed in provided data].
The BE-SAFE 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
Be-Safe Ref K935843
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mathis-Koolpe, Inc. have in the registry?
The registry currently lists 1 device for Mathis-Koolpe, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mathis-Koolpe, Inc.'s devices?
Among its 1 most recently registered device, Mathis-Koolpe, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Mathis-Koolpe, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Mathis-Koolpe, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mathis-Koolpe, Inc. in the registry?
The most recently registered devices listed for Mathis-Koolpe, Inc. include BE-SAFE.