Textil Elástico
CE Marking
The products of TEXTIL ELASTICO, S.L.U have the CE marking as Medical Devices Class 1, an essential requirement to be marketed and used inside and outside of the European Union. All products manufactured by TEXTIL ELASTICO, S.L.U meet the essential requirements and provisions of Regulation (EU) 2017/745 and Royal Decree 192/2023.
ISO 13485: 2016
TEXTIL ELASTICO, S.L.U has the Quality Management System Certificate of Sanitary Product since it meets the requirements established in the standard ISO 13485:2016. This standard refers to the medical device industry and specifies the requirements for the quality management system of organizations active in the design and manufacture of medical devices and those that design and provide related services.
ASQUAL
The French Ministry of Health requires ASQUAL certification to proceed with the Social Security reimbursement of the elastic compression products prescribed by the doctors. The manufacturer is evaluated based on its ability to reproduce the characteristics techniques of a product in a sustainable way, in particular its compression class in accordance with the regulations in force at the time of application. The issued quality certificates are valid for a period of 5 years.
OEKOTEX
TEXTIL ELASTICO, S.L.U only works with suppliers that have obtained certification Oeko-Tex Standard 100 which is a worldwide certification control system for textile raw materials, semi-finished and finished products at all stages of the process, in order to guarantee the absence of harmful substances and the health of our clients.
