Quality & certifications

To provide you with products of the highest quality and 100% in line with your needs, Laboratoires Coluxia manufacture their dressings in clean rooms of over 400m², and are ISO 13485 and ISO 9001 (GMED certification) certified. All our products are CE marked class 1 non-sterile, but we can also supply you with class I sterile medical devices marked by our parent company Gergonne Industrie.

	Possibility of manufacturing with regulatory file at customer's charge	CE-marked products, including regulatory file
Class I	Yes	Yes
Class Is	Yes	Yes*
Class IIa or IIb	Yes*	No

_{* At Gergonne Industrie}

Our quality approach is supported by responsive and regularly-trained teams as well as a human-scale organization. The quality of Laboratoires Coluxia's products and services is monitored and recognized by regular audits (LNE/G-MED).