SilberbauerService - Laser inspection

Legal basis:

All soft-laser are active medical products belonging to the class IIa and therefore require in Austria according to the Austrian medical product law §87 ff. as well as to the Austrian medical product regulation §6, in Germany according to the MPBetreibV §6, and in Switzerland according to the MepV, Art. 20, according to EN62353 regular inspection!

Performance:

Silberbauer laser devices are directly inspected in Austria at the laboratory Silberbauer in Vienna. Duration: approx. 1 hour. It is therefore necessary to send the laser including accessories (in particular batteries, all laser googles) and the INSTRUMENTS BOOK by mail or by parcel service or to directly hand over the laser device to the sales personnel at the sales office in Vienna.

The laser as well as the accessories will be inspected with calibrated measuring instruments according to legal requirements and if necessary readjusted and soft- and hardware will be updated. According to ISO13485, the results will be recorded in an inspection protocol as well as in the instruments book.

Currently, the inspection of a Silberbauer laser at the laboratory Silberbauer costs € 80.- incl. VAT, plus € 6.- for postal charges and insurances within Austria respectively € 15.- within other EU countries.