Certifications
To ensure compliance for our products, support our customers, and meet the increasing regulatory requirements, we have RA/QA competence and experts within our company, offered through our value-adding concept, Complete Performance™.
High competence in medical device standards and regulations
We offer high competence, not only based on our long experience but also on our commitment to continuous education in medical device standards and regulations.
This ensures we are always equipped to support and guide our customers in the regulatory world, adhering to international standards and country-specific jurisdictions.
Certificates:
ISO 13485:2016
ISO 14001:2015
ISO 9001:2015
ISO 13485:2021
Product certificates for own products according to EEC/MDD 93/42
MDSAP – Elos Medtech Denmark
Our cleanrooms fulfil:
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
Ruetschi Technology AG Muntelier: 3005827567
Ruetschi Technology AG Yverdon: 3014286836
Puracon GmbH Rosenheim: 3004638532
Bächler Feintech AG Hölstein: 3010287737
Klingel GmbH Pforzheim: 3004370612
Josef Ganter GmbH Dauchingen: 9680605
Download certificates here:
ISO 13485 – Memphis
EU Quality Management System Certificate – Gørløse
ISO 9001 – Gørløse
ISO 13485 – Elos Medtech AB
ISO 14001 – Elos Medtech AB
Japanese Foreign Manufacturing Certificate – Memphis
ISO 13485 – Gørløse
Japanese Foreign Manufacturing Certificate – Gørløse
EN ISO 13485 – Dauchingen
DIN EN ISO 13485 – Pforzheim
ISO 13485 – Hölstein
EN ISO 13485 – Rosenheim
ISO 9001 – Yverdon-les-Bains
Japanese Foreign Manufacturing Certificate – Muntelier
EN ISO 13485 – Muntelier and Yverdon
EN ISO 13485 – Renquishausen
