Manufacturer's declaration of conformity for MDD 92/43/EEC with an EU representative . FDA 510 K Manufacturer's certification (non-redacted) Product and packaging images showing CE markings on product and/or packaging Manufacturer's quality management certification (ISO 9001 and 13485) Product test reports (EN 455 parts 1 to 4 - all by notified body) Technical data sheets FOB price at port of loading
