Thanks Slaz. I think my confusion comes from Verticalmojo's post that said most of their products are FDA approved and have the CE mark. Obviously not the cast then. Maybe Verticalmojo can clarify what he means.
You are incorrect. The Steri-Tap product line is a Class IIa medical device and is currently able to be marketed and sold due to being manufactured in Europe. The European production facility for these instruments has been certified. We do not know who is manufacturing this product line for the company. It likely the same manufacturer will be involved in the production of the other product lines upon completion of the ISO process.
The Mammoview is a Class III medical device and the company's bariatric product line likely would be classified as a Class IIb device (which often requires the filing of clinical data). The quality management process SNDY is going through at this time is for these product lines.
Steri-Tap FDA approval/CE Mark Bariatric FDA approval Mammoview FDA approval
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