I talked to Sara from Emergo Group and she said time
Regardless of the classification of your medical device, SNDY must prepare an EU Declaration of Conformity (DOC) if you sell medical devices in Europe. The elements that should be included in the Declaration of Conformity include:
-
- Name of the device, including model number and trade name.
- Manufacturer name and address.
- Name of company quality management representative.
- Name and identification number (if applicable) of your Notified Body.
- Name, address and telephone number of your European Authorized Representative.
- Your CE Marking certificate number (if applicable).
- Your conformity assessment route to compliance. List the Annex, classification and rule number (rule number only applies to the Medical Device Directive).
- Standards that have been applied (optional)
- Name and signature of a senior management representative and date signed.
Please understand this is a normal process that is the same for any medical company applying for CE mark. EGroup likes to tell there customers it takes 6-12 weeks. The time frames are typical for the majority of medical devices submissions prepared by EGroup. The length of approval will depend on the quality and completeness of technial documentation used in the submission, additional requirements/questions from the Notified Body after submission, and how much time you take to address additional information request. FOR THIS REASON SUBMISSIONS MAY TAKE MORE TIME THAN 6-12 WEEKS! I want to make this perfectly clear to everyone now. This is straight from EMERGO GROUP!! I normally don't post this kind of DD publicly. But everyone needs to know it is getting done, and it is not some BS the company is feeding us. I'm getting sick of that $hit. If people want out then by all means sell your shares and get out. At least this board is so much better then where we were. Getting this CE Mark Certificate is in the hands of EG. This delay is normal. They will get it done!
I'm not going into all the detail of their distribution program, but they have over 12 distributors in Europe. The have large key accounts that will ramp up sales for SNDY.
Everyone keeps talking about the MammoView which is a great product, but I believe the big seller will be the Steri-Tap. It is a $3.6 billion industry with few players in the field. Huge market for SNDY. EG can also help with merger/acq. deals as well.
So we need to have a little patience and let this process go thru the steps necessary to achieve what we have all been waiting for since early last year. What is a few more months going to really matter. Folks we are about to get what we have all been waiting for.
Take care my friends,
Mike
CYduct Diagnostics Inc. (CYDX) Stock Research Links
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