Rofil Medical USA, Inc.
Country not established
- Devices
- 1
What Rofil Medical USA, Inc. makes
Rofil Medical USA, Inc. manufactures SILGEL Topical Gel Sheets, a Class I medical device designed for topical application to skin surfaces.
The device is regulated under the FDA’s 510(k) pathway and is listed in the U.S. as a Class I medical device. The company is based in the United States.
Catalogue
Silgel Topical Gel Sheet Ref K960254
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rofil Medical USA, Inc. have in the registry?
The registry currently lists 1 device for Rofil Medical USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rofil Medical USA, Inc.'s devices?
Among its 1 most recently registered device, Rofil Medical USA, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Rofil Medical USA, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Rofil Medical USA, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Rofil Medical USA, Inc. in the registry?
The most recently registered devices listed for Rofil Medical USA, Inc. include SILGEL TOPICAL GEL SHEET.