Mologic CE marked AffiDX for professional use, CE mark with #avct not Med19 AffiDX solely an avct brand. Med19 CE self use mark for Meduflow, EU CE mark solely Med19’s for Meduflow not avct. Professional & self use CE marks differ in use, both need separate CE marks.

1/23 Med19 have done all the hard work re: lay user study, filing all docs for CE mark for self use with EU notified body, as well as the money and time spent in obtaining CE self use mark for Meduflow. Med19 will be looking to keep and make a serious return on their investment

2/23

‘Who (what) is EU Notified Body Med19/#avct cld be working with’ to obtain EU IVD self use CE certificate. What EU state cld they be from, is it coincidental they are located in Spain, same city hospital area avacta used to verify AffiDX lft, Med19 have a Spainish website

1/15 On EU NANDO database from 18 Notified Bodies (NB) Med19/#avct could be working with ‘AEMPS Notified Body’ who certify med product devices under EU directive 98/79/EC for self use in-vitro diagnostic test (IVD). If not, then 17 other EU Notified Bodies to work with

2/15

#AVCT Spoke to someone at Med19 today for 1hr 46min. Not give any detailed info. Wat I will say is: HUA in very final stages, infact very little else to do. Everything asked for has been submitted, even if EU asked for it twice its been given (if u understand wat Im implying) 1/9 Global demand is huge, getting calls from global govs/busi/high caliber distributors-business men. Med19 have orders, ready to take more orders soon as HUA is given. Affidx recognized as a gold standard reliable test, easy to use. Med19 working with global distributors 2/9