This medical device is classified IIb according to the current applicable European Directive. It is CE marked. Notified Body : CE 0459 LNE-GMED. This medical devices dedicated to dental cares is restricted to health staff ; it is not reimbursed by health insurance organizations. This device was developed and manufactured according to the EN ISO 13485 quality control certification system. Read carefully the user manual. Manufacturer : SOPRO (France).
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