Medical Device means any instrument intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, treatment or alleviation of disease and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. Any advertising of Medical Devices to the public is restricted by current regulations.
The Medical Devices (MD) fall within the scope of Directive 93/42 / EEC, issued in 1993 and implemented in Italy by Legislative Decree 24.02.97, n ° 46.
Guna has obtained UNI EN ISO 13485: 2004 Medical Devices-Quality Management Systems certification regarding the processes of Design, Production and Marketing of Medical devices for:
- injectable application
- application tointernal mucous membranes
- applicationsto externalmucous membranes
Guna is the manufacturer of the following type of medical devices:
- injectable solutionsmade from collagen and specificfor pain management