We operate to U.S. FDA Good Manufacturing Practices and Standards, and are certified to ISO 13485 and ISO 9001. Our products are certified to MDD, UL and CSA and carry the CE mark as required.
Lumitex Asia Certificate of Registration of Quality Management System to ISO 9001:2015 →
Certificate of Registration of Quality Management System to I.S. EN ISO 13485:2016 →
MDD 93/42/EEC Annex II Certificate – Surgical Instrument Fiberoptic light (LightMat) →
MDD 93/42/EEC Annex II Certificate - Bilisoft 2.0 Phototherapy System →
