Lumitex Medical Devices, Inc. is certified to Medical Devices Directive 93/42/EEC Annex II — Quality System Approval.
Certified Organization:
Lumitex Medical Devices, Inc.
Headquarters:
8443 Dow Circle, Strongsville, Ohio 44136, USA.
Standard:
Medical Devices Directive 93/42/EEC Annex II — Quality System Approval
Scope of Certification:
Approval of the quality system applied by Lumitex for the product family “BiliSoft 2.0 Phototherapy System”
Registration Number:
252.1205
Certification Granted:
May 6, 2020
Effective Date:
May 6, 2020
Expiry Date:
May 26, 2024
Certifying Body:
National Standards Authority of Ireland (NSAI)
