Our biotechnology is certified according to all existing requirements.
Our biotechnology is certified by the FDA confirming that our product is complying with the United States Food and Drug Administration Center for Devices and Radiological Health’s compliance policy entitled “General Wellness: Policy for Low Risk Devices’ issued on July 29, 2016” and has the FDA guidance 1300013 (UCM429674).
The device that is used for our analysis is certified by FCC, which confirms compliance with Part 15: Federal Communications Compliance on electromagnetic emissions.
CE confirms the Assurance of Regulatory Compliance confirming that our biotechnology is authorized under CE Directive 2014/30/ EU and RoHS Directive 2011/65. It confirms that our biotechnology is compliant with general requirements: EN 61326-1:2006 EMC Requirements; EN 60950-1:2006+A12:2011; EN: 5502/55011/55024.
Intertek’s ETL Certification program confirms that our biotechnology meets the needed requirements: 1. ETL Intertek Recognized Component - 5000055; 2. UL std 60950-1; 3. Certified to CSA std. c22.2.No.60950-1.
HS Code system confirmed that the needed requirements are met and assigned a Harmonised Shipping Code - 903180 - Other checking, measuring instruments, appliances and machines.
CCC confirms that our biotechnology complies with the requirements of the Chinese Conformity Certificate for electrical compliance.
Use the trusted technology
With Epixlife you will have access to the Cell Wellbeing® S-Drive device with which you can evaluate more than 96 epigenetic markers of your patient in 15 minutes to process and offer a complete epigenetic report.
The technology has the ISO EN 13485: 2012 certificate, with all the corresponding regulations to offer the highest quality standard, guaranteeing the precision and reliability of the results.