The quality system of BTI guarantees the excellence of its products throughout their life cycle, from their design to their commercialisation.

Our products are guaranteed by the ISO 13485: 2016 and MDSAP certifications, CE marking in compliance with the European Directive on healthcare products 93/42/CEE, awarded by TÜV-SÜD Product Service GmbH.

Intended for international use only. Indications for use of products and/or therapies contained herein may not be cleared /approved for use by the following Health international agencies: US Food & Drug Administration, Health Canada or Japanese Health Ministry. To access the specific information of your market, use the country selector located on the top menu of this page.

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