Lumitex, LLC is certified to I.S. EN ISO 13485:2016 for its Quality Management System.
Certified Organization:
Lumitex, LLC
Headquarters:
6611 W Snowville Road, Brecksville, OH 44141, USA
Standard:
I.S. EN ISO 13485:2016 for its Quality Management System
Scope of Certification:
The Design and Development, Manufacture and Distribution of Sterile and Non-Sterile Medical Illumination Devices and Non-sterile
Phototherapy Devices.
Registration Number:
MD19.4787/A
Certification Granted:
March 26, 2013
Effective Date:
February 14, 2025
Expiry Date:
June 25, 2026
Certifying Body:
National Standards Authority of Ireland (NSAI)
