Edx Epi-Scan, Inc.
Country not established
- Devices
- 1
What Edx Epi-Scan, Inc. makes
Edx Epi-Scan, Inc. manufactures the EPI-SCAN, Model P 100, a device designed for non-invasive imaging of the skin’s electrical properties to assess epidermal function and barrier integrity.
The company’s portfolio is regulated under FDA Class II devices, with the EPI-SCAN, Model P 100 authorised via the 510(k) clearance pathway. The device is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Epi-Scan, Model P 100 Ref K032935
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Edx Epi-Scan, Inc. have in the registry?
The registry currently lists 1 device for Edx Epi-Scan, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edx Epi-Scan, Inc.'s devices?
Among its 1 most recently registered device, Edx Epi-Scan, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Edx Epi-Scan, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Edx Epi-Scan, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Edx Epi-Scan, Inc. in the registry?
The most recently registered devices listed for Edx Epi-Scan, Inc. include EPI-SCAN, MODEL P 100.