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Regulatory node Obelis



Country headquarter:
Market presence:
EEA Countries (EU, Iceland, Liechtenstein, Norway and Croatia).
General description:

The Obelis European Authorized Representative Center (O.E.A.R.C.) has been established in Brussels since 1988. Located at the heart of the EU, we provide European Authorized Representative (EC REP) and CE marking advisory services to manufacturers all over the world in accordance with European Directives and Regulations.

Areas of regulatory/reimbursement support:

CE marking services, incl. Authorized Representative Services for medical devices, classification, identification of EU standars, technical documentation, product notification and registration to national EU Authorities.

Company website


The eHealth Hub project has received funding from the European Union’s Horizon 2020
Research and Innovation Programme under Grant Agreement No727683.