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Quality approach

A commitment to quality
Since our founding, we have worked with a spirit of maximum quality. Today, we are certified ISO 9001 and NF EN ISO 13485.
Our goal is to offer products and quality services that meet customer and regulatory requirements.
The development of all our product ranges in collaboration with our customers is the guarantee of their satisfaction.

All the products we manufacture are CE marked (issued by the notified organization LNE/ GMED) in accordance with Directive 93/42/EEC.

Sterilization
Our products are sterilized with ethylene oxide in compliance with the requirements of the EN 550 standard. They may also be sterilized with gamma radiation according to the requirements of the EN 552 standard.

Blood lines and arterio-venous kits
Our lines and arterio venous kits are made in clean rooms (ISO8 class), then sterilized on the production site (standard EN 550).
They may also be sterilized with gamma radiation according to the requirements of the EN 552 standard.

Packaging
Single or double packed.