ZenGUARD(TM) Enhanced Air Filters to Be Added as Class 1 Medical Device Under Zentek's Medical Device Establishment Licence
By:
ACCESSWIRE
November 27, 2024 at 08:45 AM EST
GUELPH, ON / ACCESSWIRE / November 27, 2024 / Zentek Ltd. ("Zentek" or the "Company") (Nasdaq:ZTEK)(TSX-V:ZEN), an intellectual property development and commercialization company, announces its decision that its ZenGUARD™ Enhanced Air Filters will be added under the company's existing medical device establishment licence ("MDEL"), similar to ZenGUARD™ Surgical Masks.
Quality Management System Prior to distributing and selling an additional medical device in Canada, certain testing, process updates and additional documentation related to the Company's supply chain will be required to qualify ZenGUARD™ Enhanced Air Filters as a medical device under its MDEL and ensure compliance with its ISO 13485:2016 Quality Management System. While this process will take additional time and resources, the Company expects it to be significantly less than that required under the previous pathway to market being pursued. "ZenGUARD™ Enhanced Air Filters will offer a safe and effective way to help prevent the transmission of disease indoors without increasing energy consumption and emissions. This unique value proposition was borne out of an ask from the Government of Canada's Innovation Science and Economic Development agency - and we look forward to fulfilling that ask and helping many others in Canada with a safe and effective technology," said Greg Fenton, CEO of Zentek. Management Changes The Company also announces that Nick Hansford, Vice President, Strategy and Product Development, and member of the Zentek management team, has left the company to pursue other opportunities. About Zentek Ltd. Zentek is an ISO 13485:2016 certified intellectual property technology company focused on the research, development and commercialization of novel products seeking to give the Company's commercial partners a competitive advantage by making their products better, safer, and greener. Zentek's patented technology platform ZenGUARD™ is shown to have enhanced viral filtration efficiency for surgical masks and aims to do the same for HVAC (heating, ventilation, and air conditioning) systems. Zentek's ZenGUARD™ production facility is in Guelph, Ontario. For further information on Zentek: Ryan Shacklock To find out more about Zentek, please visit our website at www.Zentek.com. A copy of this news release and all material documents in respect of the Company may be obtained on Zentek's SEDAR+ profile at http://www.sedarplus.ca/. Forward-Looking Statements This news release contains forward-looking statements. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Although Zentek believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. Zentek disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. SOURCE: Zentek View the original press release on accesswire.com More NewsView More
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