ISO 13485:2016
Medical Devices — Quality Management System
Certified for the manufacturing of medical examination gloves. ISO 13485:2016 is the international standard for quality management systems in the medical device industry.Certificate available upon request.
Obelis European Authorized
Obelis S.A. is our European Authorized Representative for CE-marked examination gloves sold in the EU.
SATRA EU Type Examination
Our products meet the essential requirements of the applicable European CE Directives, enabling distribution across the European Economic Area.Certificate available upon request.