Anyfusion cartridge set reclassified as new technology medical device from KFDA.

Anyfusion pump has classified new technology device since 2016 in KFDA.

However, their part Anyfusion cartridge set was still classified as existing IV set item.

For this reason, cartridge set has evaluated existing general IV set without recognition of new technology applied device corresponding to the standard of KFDA: IV set defined that use only fluid not medicine.

Nevertheless Anyfusion cylinder cartridge is already classified as cylinder cartridge( new medical device) according to CE GMDN code, KFDA had yet classified as IV set category.

Reflection of CE standard, KFDA also passed cylinder set as new medical device.

For this achievement, not only Korea also foreign countries will be served english version document of KFDA classification.

KFDA evaluated our cartridge set meet new medical device standard also already it passed Europe GMDN code.

It means that cylinder set is revaluated as new technology medical device.

Thanks for all the striving related persons.