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Obelis Group

The Obelis Group encompasses GiDoS s.p.r.l., as well as the Obelis European Authorized Representative Center.

Obelis s.a.

Obelis European Authorized Representative Center (OEARC) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European medical device manufacturers' successful endeavors into Europe. Obelis (ISO Certified and E.A.A.R. member) services include: E.A.R., CE Marking consulting, EU Harmonized Standards Identification, P.M.S, Free Sales Certificate, GMDN Code Research, Device Registration, Trade Mark Submission, and more.

Obelis' OneLink One Solution™ (O.L.O.S.) robust compliance network includes regulatory experts from around the world providing international regulatory support and language compliance alongside superior international representation in Australia, Brazil, Canada, China, India, Israel, Korea, Malaysia, Thailand, USA and the Philippines - "For the Mutual Benefit of the Mutual Clients."

Obelis provides integrated regulatory solutions for the following European Directives and Regulations: MDD 93/42/EEC & 2007/47/EC, IVDD 98/79/EC, PPE 89/686/EEC, LVD 2006/95/EC, EMC 2004/108/EC, MSD 98/37/EC & 2006/42/EC, R&TTE 99/5/EC, Cosmetic 78/768/EEC, GPSD 2001/95/EC, and TSD 88/378/EEC.

Please visit the Obelis website.