Replies to post #57545 on CYduct Diagnostics Inc (CYDX)

[slazenger7]

1. The company doesn't have to have a distributor in Europe to attain the CE Mark. A distributor in Europe or anywhere for that matter has nothing to do with getting the CE Certification, it has to do with sales and marketing. They will most likely get one after they attain the CE Certification, or could be negotiating with one now.

2. SNDY doesn't have the CE Certification to sell any of its products yet because it hasn't finished the CE Certification process yet. Note the timeline on the company website for CE Certification.

http://www.solosendoscopy.com/press-releases/SNDY-ISO-13485-CE-Mark-Project-Schedule-June-2013.pdf

3. You are confusing FDA approval and CE Certification on current SNDY products. SNDY has FDA approval on its products, not the CE Certification. Once they pass the final audit and get the CE Certification, they will be able to sell all their FDA approved products overseas. However, they don't need FDA approval to sell their products overseas, just the CE Certification. The FDA approval is a plus for them and adds to the marketability of their products.