Compliance documents, not just badges. Six product families — surgical lights, operating tables, examination lights, medical headlights, loupes and film viewers — are each covered by a CE declaration of conformity under EU MDR 2017/745, manufactured under ISO 9001:2015 and ISO 13485:2016 quality systems. We also hold U.S. FDA registration, a Certificate of Free Sale and a Class II China production licence for surgical lighting equipment. Each document states its scope and validity date.