EUDAMED update: May 20, 2026

Obelis s.a.

BE-AR-000000106

Authorised representativeActive

Address: Boulevard Général Wahis, 53 1030 Brussels
Role: Authorised representative
Date of registration: Dec 7, 2020
Country: Belgium

Obelis s.a. is an EU authorised representative registered in EUDAMED. Headquartered in Brussels, Belgium. Explore the regulatory profile, devices and certificates on MD Atlas.

About Obelis

: BE-AR-000000106
Role: Authorised representative
Country: Belgium
Organization name: Obelis s.a.
EU VAT number: BE 0435 456 853
Date of registration: Dec 7, 2020

Contact details for Obelis

Phone: +32(2)73 25 954
Email: regulatory@obelis.net
Website: www.obelis.net
Address: 53, BOULEVARD GÉNÉRAL WAHIS 1030 BRUSSELS BELGIUM

Officers and regulatory representatives of Obelis

FERRETTI Sandra
Ensures all Obelis processes comply with both MDR and IVDR, and are monitored for compliance according to QMS.
Hidden
ELKAYAM Doram
Ensures Obelis fulfils its AR obligations towards MF according to both MDR and IVDR (Minimum mandate tasks, Recommend termination of mandate).
Hidden
TURCHI Davide
Ensures Obelis fulfils its AR obligations towards MF according to both MDR and IVDR (Minimum mandate tasks, Recommend termination of mandate).
Hidden

Competent authority

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten

Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

Role and obligations in EUDAMED

An authorised representative is an entity established in the European Economic Area that a manufacturer based outside the EEA appoints to act on its behalf for specified regulatory tasks. Registration in EUDAMED is required under Article 11 of the MDR (2017/745) and Article 11 of the IVDR — règlement (UE) 2017/746.