The technology is ISO EN 13485: 2012 certified, with all the corresponding regulations to offer the highest quality standard, guaranteeing the accuracy and reliability of the results.
The device used for our analysis is FCC certified, which confirms compliance with Part 15: Federal Communications Compliance for Electromagnetic Emissions.
CE confirms the Regulatory Compliance Assurance by confirming that our biotechnology is approved according to EC Directive 2014/30 / EU and RoHS Directive 2011/65. It confirms that our biotechnology complies with the general requirements: EN 61326-1:2006 EMC Requirements; EN 60950-1:2006+A12:2011; EN: 5502/55011/55024.
Our biotech is certified by the FDA as a product that complies with the U.S. Food and Drug Administration's Center for Devices and Radiological Health compliance policy entitled "General Wellness: Policy for Low Risk Devices 'issued July 29, 2016" and has FDA guidance 1300013 (UCM429674).
Intertek's ETL certification program confirms that our biotechnology meets the necessary requirements: 1. Intertek Recognized ETL Component - 5000055; 2. UL std 60950-1; 3. Certified to CSA std. c22.2.No.60950-1.
The HS Code system confirmed that the necessary requirements were met and a Harmonized Shipping Code was assigned - 903180 - Other testing, measuring instruments, apparatus and machines.
CCC confirms that our biotechnology meets the requirements of the Chinese Certificate of Conformity for electrical compliance.
