Manufacturer
Medela AG
Lättichstrasse 4b
6341 Baar / Switzerland
Phone +41 (0)41 769 51 51
Fax +41 (0)41 769 51 00
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As a Manufacturer and Supplier of Medical Devices Medela AG has established a Quality Management System
that is certified according EN ISO 9001 and EN ISO 13485/CMDCAS. Medela AG meets the requirements of FDA
21 CFR part 820 as well as other international quality system regulation.
Medala Products that are classified as Medical Devices fulfill the essential requirements of the Medical Device
Directive 93/42/EEC and are therefore labeled with the CE marking.