Quality

Ulax is FDA registered and operates a quality management system certified in accordance with SS-EN ISO 13485:2016. The company also holds EU certification under the Medical Device Regulation (EU) 2017/745, including Production Quality Assurance in accordance with Annex IX, Chapters I and III, for medical devices.

Environmental responsibility is an integral part of our operations. When selecting production methods and materials, we place strong emphasis on sustainability and environmental impact. Our quality policy ensures full traceability of both materials and labor throughout every stage of the manufacturing process — from raw materials to finished products.

Downloads

• EU  Certificate (PDF)
• SS-EN ISO 13485:2016 Certificate (PDF)