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Quality

AMD ESAFARMA is certified according to the standards UNI EN ISO 9001:2008 UNI EN ISO 13485:2012 and produces its line of medical disposable devices in the modern plant located in Terontola. The factory has been designed to carry out the production cycle according to the GMP indications (Good Manufacturing Products). The plant is equipped of cleanrooms, which ensure that all the production stages occur in a place where particles contamination is controlled and guarantee the products EC certification.

AMD ESAFARMA has certificated all the nonwoven products according to the standards EN 13795‐1‐2‐3.

All the products are exclusively manufactured by AMD ESAFARMA and they are all EC marked by the Italian High Health Institute (0373) in class I, IIa, IIb and III.

Furthermore, AMD ESAFARMA owns the authorization, given by the Italian Ministry of Health, to the distribution and the insertion of pharmaceutical specialties, which are necessary in the composition of specialized kits.