Would the proposed EU medical-device classification require notified-body assessment of the antimicrobial function or allow self-declaration?
Last reviewed: .
Would the proposed EU medical-device classification require notified-body assessment of the antimicrobial function or allow self-declaration?
The company does not place a medical device on the European market and gives no medical device classification for a NanoFlashing™ material.
As of the Effective Date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications. They do not describe finished products currently available from C-POLAR for those uses. Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. For the air filter, the label states: “It is not a medical device and is not intended to diagnose, treat, cure or prevent disease.”
Source: C-POLAR — Terms of Use, https://cpolar.tech/terms/; C-POLAR — About, https://cpolar.tech/about/; NanoFlashing™ Air Filter label.
Reviewed on .
Sources
- C-POLAR — Terms of Use
- C-POLAR — About
- NanoFlashing™ Air Filter label