I was importing and selling the Mamivac nipple shields (including the 28s) in the USA until the FDA requirements changed in January 2013. I was going to be charged $2500 to be an initial importer and then had to meet requirements as a manufacturer including hiring my own independent quality assurance provider. It became more than I could do which was very disappointing. Mamivac could not assist us with any of the regulations as much as they tried. I do believe someone else has taken over the USA but at a higher per product fee than I was charging. It must be due to the fees imposed.
Dana Schmidt, RN, IBCLC
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