Committed to product performance and excellence

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™.

High competence in medical device standards and regulations

We offer high competence based on long experience and continuous education in medical device standards and regulations to support and guide our customers in the regulatory world, both according to international standards as well as country-specific jurisdictions.


ISO 13485:2016
ISO 14001:2015
Product certificates for own products according to EEC/MDD 93/42
MDSAP – Elos Medtech Denmark

Our cleanrooms fulfill

ISO 14644-1

Registration number at FDA

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

Download certificates here:

ISO 13485 FM 655347 20240501
EU Quality Management System Certificate Elos Medtech Gørløse issued May 03 2023
ISO 13485 Cert Elos Medtech Memphis issued June 2021
ISO 9001
ISO 13485
ISO-14001-258077-2018 Management System Certificate Appendix
Japanese Foreign Manufacturing Certificate, Onyx Medical LLC
MDSAP 703575 Elos Medtech Gørløse issued Oct 17, 2019
Japanese Foreign Manufacturing Certificate, Elos Medtech Gorlose