CE MARK

Calze GT S.r.l. products have CE Mark, they have then the essential requirements to be marketed and used in and outside the European Union. All product lines RelaxSan, FarmaCell and RelaxMaternity and are Class I medical devices and comply with the essential requirements and provisions of EEC Directive 93/42.

FDA

Calze GT S.r.l. products are accredited by the Food and Drug Administration (FDA), the Agency of the Department of Health and Human Services of the United States, which aims to protect public health, safety and efficacy of products marketed in the US.

UNI EN ISO 9001 & UNI CEI EN ISO 13485

Calze GT S.r.l. have the quality management system Certification as it is complying with UNI EN ISO 9001:2008 and UNI EN ISO 13485:2004 for the following activities: development and production of medical stockings, orthopedic textile, clothing and seamless underwear on customer specifications and medical creams.