SOLTEC is an Italian company with over twenty years’ experience in the manufacture of ultrasonic cleaners marketed under the SONICA brand and related accessories.

• We provide you with highly-qualified personnel to best meet your needs, assisting you in every detail during the purchase process, by performing a thorough analysis of your expectations and needs.

• We look after you from the moment we receive your order until delivery of the goods, entrusting shipment to the best carriers on the market.

• We provide a Warranty on all items purchased, while we can also provide you with insurance cover, on request, for your goods during shipment until they are delivered to your address.

• We offer highly-qualified After Sales service and especially Technical Assistance if your ultrasonic cleaning equipment stops working, even many years after the purchase date. Each repair is carried out exclusively by specialized technicians using original SONICA components at our repair workshop at our manufacturing site in Milan.

The SONICA ultrasonic cleaning equipment range manufactured by SOLTEC are medical devices, and as such, comply with the provisions of Italian Legislative Decree No 46 dated 24 February 1997 and subsequent amendments.
For these devices SOLTEC S.r.l. has complied with the provisions of Italian Legislative Decree No 46 dated 24 February 1997 and its subsequent amendments. CE marking has been requested for the SONICA L Ultrasonic Automatic Multifunction System [Class IIB Medical Device] from a Notified Body [Kiwa Cermet Italy].
For the design and manufacture of SONICA ultrasonic cleaning equipment, SOLTEC has complied with the following STANDARDS:

• DIRECTIVE 93/42/EEC dated 14 June 1993 and subsequent amendments

• DIRECTIVE 2007/47/EC.

• ITALIAN LEGISLATIVE DECREE No 46 dated 24 February 1997, and subsequent amendments

• UNI EN ISO 9001:2015

• UNI IEC EN ISO 13485:2012.

• IEC EN 980:2009. Symbols to be used with medical device labels, labelling and information to be supplied.

• UNI IEC EN ISO 15223-1:2012 - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements.

• UNI IEC EN 1041:2013- Information supplied by the manufacturer of medical devices.

• UNI IEC EN ISO 14971:2012. Medical devices - application of risk management to medical devices.

• ITALIAN MINISTRY OF HEALTH DECREE dated 15 November 2005.

• Italian Ministry of Health decrees dated 20 March 2007 and 21 December 2009.

• MEDDEV. 2.7.1 Rev. dated 3 December 2009 - Guidelines on medical devices, clinical evaluation: a guide for manufacturers and notified bodies.

• MEDDEV 2.4/1 Rev. dated 9 June 2010 - Guidelines Relating To The Application Of The Council Directive 93/42/EEC On Medical Devices.

• MEDDEV 2.12 -1 Rev. 8 January 2013 - Guidelines on the vigilance system for medical devices.

• IEC EN 62304: 2006 - Medical device software - Software life cycle processes.

• EN 61010-1 - Safety requirements for electrical equipment for measurement, control, and laboratory use.

• EN 61326-1 - Electrical equipment for measurement, control and laboratory use - EMC requirements .

• EN 61010-2-040 - Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials.

• UNI EN ISO 10993-1:2010 - Biological evaluation of medical devices - Part 1: Evaluation and testing in the risk management process.

• ITALIAN LEGISLATIVE DECREE No 49 dated 14 March 2014: Implementation of Directive 2012/19/EU regarding waste from electrical and electronic equipment (WEEE).

• DIRECTIVE 2011/65/EC RoHS II dated 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

• IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Our Certifications

Consult all the other certificates obtained by SOLTEC