Committed to product performance and excellence

In order to ensure compliance for our own products, support our customers and meet the increasing regulatory requirements, we have RA/QA competence and experts within our company, which is offered through our value-adding concept Complete Performance™. We offer high competence based on our long experience and continuous education within medical device standards and regulations to support and guide our customer in the regulatory world, both according to international standards as well as country specific jurisdictions.

Certificates

ISO 13485:2016
ISO 14001:2015
Product certificates for own products according to EEC/MDD 93/42

Our clean rooms fulfill

ISO 14644-1, class 7

Registration number at FDA

Elos Medtech Pinol A/S: 3007689689
Elos Medtech Timmersdala AB: 3003847101
Elos Medtech Microplast AB: 3012416874
Onyx Medical LLC: 1043653

Download certificates here:
EC product certificate Elos Medtech Pinol AS issued Dec 19, 2017
ISO 13485 CMDCAS, Elos Medtech Pinol A/S
ISO 13485:2003 Certificate Onyx Medical
ISO 9001 Elos Medtech Pinol  A/S issued April 2018
ISO 13485 Certificate Elos Medtech AB issued April 13, 2018
ISO 14001 Certificate Elos medtech AB including business centers in Appendix
Japanese Foreign Manufacturing Certificate, Onyx Medical LLC