Regulatory Compliance

At DANU Medical, quality is embedded in everything we do. Our Quality Management System (QMS) is compliant with FDA 21 CFR Part 820 and aligned with ISO 13485:2016, the global standard for medical device quality systems.

Our medical device has been registered and listed with the U.S. Food and Drug Administration (FDA) as a Class I exempt device.

We are committed to continuous improvement and patient safety — delivering trusted, high-quality medical technology.

•⁠  ⁠Quality Management System aligned to ISO 13485:2016
•⁠  ⁠Compliant with FDA 21 CFR Part 820
•⁠  ⁠Class I device listed with the U.S. FDA
•⁠  ⁠Establishment registered with the U.S. FDA

CE & FCC

The product hardware has been certified for CE and FCC Certifcation by Compliance Engineering Ireland (CEI) for:

Electromagnetic Compatibility (EMC)
Radio Equipment Directive (RED) (Testing standard: EN 300 328)
Audio/Video Equipment Safety (Testing standard: EN IEC 62368-1:2020)

The Danu device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that  may cause undesired operation.

WARNING: Changes or modifications not expressively approved by the party responsible for compliance could void the user’s authority to operate the equipment.Radiation Exposure
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment can be installed and operated with a minimum separation distance of ≤ 5 mm between the equipment and users/bystanders.