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:
8300 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 “Surgical instrument fibreoptic light (LightMat)” focused on conformity under MDD requirements.
Registration Number:
252.914
Certification Granted:
November 14, 2013
Effective Date:
March 3, 2021
Expiry Date:
September 24, 2023
Certifying Body:
National Standards Authority of Ireland (NSAI)
