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Certificate of Conformity - FKG
Certificate of Conformity - FKG
We hereby certify that, the above-mentioned products have been manufactured according to the
technical specifications of the customer’s tender, purchase order or sub-order and that, having
carried out all relevant inspection procedures and tests, the products correspond in every aspect to
the applicable specifications as well as to the relative standards and regulations in force.
Furthermore, we declare that the above-mentioned products meet the provisions of the Council
Directive 93/42/EEC for medical devices as amended by 2007/47/EC and all applicable requirements
of ISO 13485:2016
BAIZE Romain
Quality & Regulatory Affairs Director
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