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).

Made in France French manufacturer of dressings and patches since 1926

For professionals Dedicated exclusively to the BtoB market

100% integrated production Mastery of each step: development, formulation, coating, cutting...

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