Company quality and product certifications

CE MARK
Calze GT products achieved the CE marking as Medical Devices Class 1, an essential requirement to be marketed and used within and outside the European Union. All the Relaxsan products comply with the essential requirements and provisions of Directive 93/42/EEC.

UNI CEI EN ISO 13485:2016
Calze G.T. S.r.l. owns the quality management system Certificate because it complies with UNI CEI EN ISO 13485:2016. The UNI EN ISO 13485:2016 International Standard regards the medical device industry and specifies the requirements for the quality management system of organisations active in designing and manufacturing medical devices and those that design and provide related services.

STANDARD 100 BY OEKO-TEX
Calze GT products* have obtained the Oeko-Tex Standard 100 certification (world certification controls system for raw textiles, semi-finished and finished products, at all stages of the process) to ensure the absence of harmful substances and the health of our customers.

*Products containing Crabyon yarn and Yaluronica products are not included in the certification.

UNI EN ISO 9001:2015
Calze G.T. S.r.l. owns the quality management system Certificate because it complies with UNI EN ISO 9001:2015 for the following activities: certification: development and production of medical hosiery and orthopedics textile articles; Production of seamless cloths and underwear according to customer specification.

FDA MARK
Calze GT is an FDA (Food and Drug Administration) registered company, the Agency of the United States Department of Health and Human Services, which aims to protect public health, safety and efficacy of products marketed in the US.

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