Hi,
We include the catheter and syringe into one blister package. Then after sterilization the blister is placed into individual carton box with IFU and sterile CE marked lubricated jelly.
Are there any FDA and CE stricked requirements/ directives of what information should be on the box label.
As I know the european authorities allow not to place CE mark on the box as the components inside the box as CE numbers are different. Is it correct? and what about FDA?
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Zoya Lee
RA
Degania Silicone Ltd
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