CuraMedical can rely on a substantial record of sales without reportable complaints or adverse incidents which has proven our product’s efficacy and performance. The quality manual of CuraMedical B.V. and further required documented procedures have been reviewed by the notified body MDC (CE 0483) with respect of the requirements of the Medical Device Directive 93/42/EEC, Annex II, and EN ISO 13485:2003.
Download our ISO 13485 Quality certificate
The design dossiers and technical files for the products Curaspon®, Curacel® and Curatamp® have been successfully examined and awarded CE certification. Our certificates can be downloaded here: