TRATE AG is a Swiss-based company which is the legal manufacturer of medical devices, owning a production site in the European Union. TRATE specializes in design, development, manufacturing, marketing and distribution of dental and maxillofacial products, such as the dental implant system ROOTT with related dental superstructures and surgical instruments.

 

At the core of the enterprise is the practical experience of a dentist, deep production knowledge and understanding of what is necessary for the successful functioning of dental clinics. We aim to maximize efficiency in the production and distribution of our products while maintaining high quality and safety standards. We have our own global distribution network, which allows us to guarantee world-class service.

 

We operate on the quality management system based on EN ISO 13485:2012 as confirmed by the international certificate from leading global notify body – BSI (United Kingdom).

 

Our products are certified in compliance with the provisions of the European Medical Device Directive 93/42/EEC Annex II and Annex V. In all countries where TRATE’s products are officially presented by a local dealer, TRATE has local safety and quality certificates.

 

Our own production site is located within the EU (TRATE UAB), where we carry out turning on Swiss-type lathes, surface treatments, quality control, washing and disinfection, as well as clean room packaging.

 

The production site has a building of around 900 m2, with 5 Swiss-type lathes, ISO 6 & ISO 7 clean rooms, different equipment for surface treatment, cleaning and packaging from leading manufacturers from Switzerland, Germany and Italy. The production is running 24 hours per day, 7 days per week, with around 50 employees, and producing about 20 000 different components per month.

 

TRATE is using raw materials from the leading manufacturer of medical alloys company Zapp AG (Germany) which is a trustful global supplier for the medical industry.

 

Sterilization of products is outsourced to a leading supplier for gamma sterilization and microbiological testing of medical devices by a company BBF Sterilisations-service GmbH (Germany), which is accredited by the German national accreditation body DAkkS and certified according to ISO 9001, ISO 13485 and ISO 11137 to provide gamma sterilization and validation according to ISO 11137. For TRATE they are also providing microbiological laboratory services, packaging validation according to ISO 11607-1, and cleaning validation.

 

The final release of products, design and developing, test and research, local and global certification, issuing permission for sales and product distribution are taken care by TRATE AG (Switzerland).

 

TRATE has an international team of open-minded professionals, who love what they are doing and applying all their knowledge for creating safe high quality products.