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
