Zentek to Classify ZenGUARD™ Enhanced Air Filters as Class 1 Medical Device

ZTEK
November 01, 2025

Zentek Ltd. announced its decision to add its ZenGUARD™ Enhanced Air Filters under the company's existing medical device establishment licence (MDEL). This classification is similar to that of its ZenGUARD™ Surgical Masks.

This move positions the enhanced air filters as a Class 1 medical device, which is a crucial regulatory step for broader market acceptance and commercialization.

The classification streamlines the pathway for these filters to be utilized in various healthcare and public safety applications, leveraging the established MDEL framework.

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