Mondeal North America, Inc.
Country not established
- Devices
- 1
What Mondeal North America, Inc. makes
Mondeal North America, Inc. manufactures the Endoscopic Tissue Recession and Release System, a device designed for minimally invasive surgical procedures to reposition tissue within the body.
This product is classified as a Class II medical device under FDA regulations and is listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mondeal North America, Inc. have in the registry?
The registry currently lists 1 device for Mondeal North America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mondeal North America, Inc.'s devices?
Among its 1 most recently registered device, Mondeal North America, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Mondeal North America, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Mondeal North America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mondeal North America, Inc. in the registry?
The most recently registered devices listed for Mondeal North America, Inc. include MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM.