Our Commitment to Your Health
Your health and safety is most important to us.
We want to make sure that our CPAP masks are produced with the utmost care, strict reliability, and strong quality control that you deserve.
Certifications
For this purpose, we are currently in the process of applying for 3 separate, yet crucial certifications:
ISO 13485
Quality management system for medical devices. This ISO is very crucial in ensuring that all our processes, from purchasing, development, to production are all diligently recorded, measured, and monitored.
CE Mark
This certification will allow us to sell our customised masks in the EU region, and unlocks many other regions as well. Through this certification process, our mask design and production process will be rigorously tested against existing standards.
FDA Approval
Similar to the CE Mark, but for the USA! This also makes sure that our design and production process are up to par.
What We Have
In the meantime, we are happy to tell you what we already have:
Our special silicone material have been proven to be fully biocompatible, even implantable for up to 29 days! It is designed to be FDA-compliant, ISO 10993-1-compliant, and even CE-Mark-compliant.
Our polycarbonate mask frame and valves have been, on their own, certified with the CE-mark. This means that they are extremely safe and reliable, and will be able to accompany you to sleep for months on end without problems!
We’ll do our best to hasten our regulatory approval, and bring our masks to you as soon as we can!
To be the first to know, simply preorder by typing in your email address here (no payment or credit card information necessary!)
