GC
GC
GC
EC DECLARATION OF CONFORMITY
According to Annex V of MDD 93/42/EEC
We ensure and declare under our sole responsibility that the products :
meet the provisions of Council Directive 93/42/EEC, concerning Medical Devices, which apply to
them, and are manufactured in accordance with the technical documentation.
The product complies with the applicable standards specified in the List of Applied Standards at
GC Orthodontics Europe GmbH.
GC Orthodontics Europe GmbH holds EC Certificate No..593589 valid until 26 May 2024 based
on Producition Quality Assurance per MDD 93/42/EEC, Annex V.
The Quality Management System of GC Orthodontics Europe GmbH is certified per ISO
13485:2016 and EN ISO 13485:2016.
Notified Body: British Standards Institution located at Say Building, John M. Keynesplein 9, 1066
EP, Amsterdam, the Netherlands. Notified Body Number: 2797.
Page 1 of 242
LIST OF PRODUCTS