Dear Doctor,

In the USA all Dermaroller® models and Beauty Mouse® are listed as: Manual Surgical Instruments for general Use, Class I.
In the European Union all Dermaroller models are approved medical devices according to the European Medical Device Directive MDD 93/42 EEU. They are classified as follows:
Dermaroller model C8 (Home Care Dermaroller): Class I, reusable surgical instrument.
Medical Dermaroller models CIT8, MF8, MS4: Class IIa, SINGLE USE surgical instruments
Our manufacturing process is certified according ISO13485.
Dermaroller® and Beauty Mouse® are patented and registered Trademarks.