Zentek Provides Regulatory Update on ZenGUARD(TM) Enhanced Air Filters
Zentek (NASDAQ:ZTEK) announced a regulatory update regarding its ZenGUARD™ Enhanced Air Filters in Canada. Health Canada is currently evaluating the product's classification and has requested additional information from the company.
Previously, on October 31, 2024, Zentek had withdrawn its submission from the Health Canada Pest Management Regulatory Agency (PMRA) to pursue an alternative commercialization pathway. The company subsequently announced on November 27, 2024, its intention to market the air filters as a Class I medical device under its existing Medical Device Establishment License (MDEL), similar to its surgical masks.
Zentek (NASDAQ:ZTEK) ha comunicato un aggiornamento normativo riguardante i suoi filtri aria migliorati ZenGUARD™ in Canada. Health Canada sta attualmente valutando la classificazione del prodotto e ha richiesto ulteriori informazioni all'azienda.
In precedenza, il 31 ottobre 2024, Zentek aveva ritirato la sua domanda dall'Agenzia per la regolamentazione della gestione dei parassiti di Health Canada (PMRA) per seguire una via alternativa di commercializzazione. Successivamente, il 27 novembre 2024, la società ha annunciato l'intenzione di commercializzare i filtri aria come dispositivo medico di Classe I sotto la sua attuale Licenza per l'istituzione di dispositivi medici (MDEL), similmente alle sue maschere chirurgiche.
Zentek (NASDAQ:ZTEK) anunció una actualización regulatoria sobre sus filtros de aire mejorados ZenGUARD™ en Canadá. Health Canada está evaluando actualmente la clasificación del producto y ha solicitado información adicional a la empresa.
Anteriormente, el 31 de octubre de 2024, Zentek retiró su solicitud de la Agencia Reguladora de Manejo de Plagas de Health Canada (PMRA) para buscar una vía alternativa de comercialización. Posteriormente, el 27 de noviembre de 2024, la compañía anunció su intención de comercializar los filtros de aire como un dispositivo médico de Clase I bajo su actual Licencia de Establecimiento de Dispositivos Médicos (MDEL), similar a sus mascarillas quirúrgicas.
Zentek (NASDAQ:ZTEK)는 캐나다에서 ZenGUARD™ 향상된 공기 필터에 대한 규제 업데이트를 발표했습니다. 캐나다 보건부는 현재 제품 분류를 평가 중이며 회사에 추가 정보를 요청했습니다.
이전에 2024년 10월 31일, Zentek는 캐나다 보건부 해충 관리 규제 기관(PMRA)에 제출한 신청서를 철회하고 대체 상업화 경로를 모색하기로 했습니다. 이후 2024년 11월 27일, 회사는 기존 의료기기 설립 허가증(MDEL) 하에 수술용 마스크와 유사하게 이 공기 필터를 클래스 I 의료기기로 판매할 계획임을 발표했습니다.
Zentek (NASDAQ:ZTEK) a annoncé une mise à jour réglementaire concernant ses filtres à air améliorés ZenGUARD™ au Canada. Santé Canada évalue actuellement la classification du produit et a demandé des informations supplémentaires à l'entreprise.
Précédemment, le 31 octobre 2024, Zentek avait retiré sa soumission auprès de l'Agence de réglementation de la gestion des pesticides de Santé Canada (PMRA) afin de poursuivre une autre voie de commercialisation. La société a ensuite annoncé, le 27 novembre 2024, son intention de commercialiser les filtres à air en tant que dispositif médical de classe I sous sa licence d'établissement de dispositifs médicaux (MDEL) existante, similaire à ses masques chirurgicaux.
Zentek (NASDAQ:ZTEK) gab ein regulatorisches Update zu seinen ZenGUARD™ Enhanced Air Filters in Kanada bekannt. Health Canada bewertet derzeit die Produktklassifizierung und hat zusätzliche Informationen vom Unternehmen angefordert.
Bereits am 31. Oktober 2024 hatte Zentek seinen Antrag bei der Pest Management Regulatory Agency (PMRA) von Health Canada zurückgezogen, um einen alternativen Vermarktungsweg zu verfolgen. Das Unternehmen kündigte anschließend am 27. November 2024 an, die Luftfilter als Medizinprodukt der Klasse I unter seiner bestehenden Medical Device Establishment License (MDEL) zu vermarkten, ähnlich wie seine chirurgischen Masken.
- None.
- Regulatory uncertainty regarding ZenGUARD™ Enhanced Air Filters classification in Canada
- Previous regulatory submission withdrawal from PMRA indicates potential challenges in product classification
GUELPH, ON / ACCESS Newswire / June 26, 2025 / Zentek Ltd. ("Zentek" or the "Company") (NASDAQ:ZTEK)(TSXV:ZEN), an intellectual property technology development and commercialization company, reports that it has received a letter from Health Canada noting that Health Canada is considering the classification of ZenGUARD™ Enhanced Air Filters and inviting Zentek to submit additional information regarding appropriate regulatory classification.
ZenGUARD™ Enhanced Air Filters were being assessed by the Health Canada Pest Management Regulatory Agency ("PMRA") for registration under the Pest Control Products Act. On October 31, 2024, the Company announced that it had withdrawn its submission to PMRA for its ZenGUARD™ Enhanced Air Filters to pursue a more appropriate pathway to commercialization in Canada. Accordingly, on November 27, 2024, the Company announced its intention to market ZenGUARD™ Enhanced Air Filters as a Class I medical device under its existing MDEL, similar to its surgical masks.
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 significantly increase the bacterial and viral filtration efficiency for surgical masks and aims to do the same with HVAC (heating, ventilation, and air conditioning) filters. Zentek's ZenGUARD™ production facility is in Guelph, Ontario.
Zentek, through its wholly owned subsidiary, Triera Biosciences Ltd., has a global exclusive licence to the aptamer-based platform technology developed by McMaster University, which is being jointly developed by Zentek and McMaster for both the diagnostic and therapeutic markets.
For further information:
investorrelations@zentek.com
Ryan Shacklock
Email:rshacklock@zentek.com
306-270-9610
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 Ltd.
View the original press release on ACCESS Newswire
FAQ
What is the current regulatory status of Zentek's ZenGUARD™ Enhanced Air Filters in Canada?
Why did Zentek (ZTEK) withdraw its PMRA submission for ZenGUARD™ Enhanced Air Filters?
How does Zentek plan to market ZenGUARD™ Enhanced Air Filters in Canada?
When did Zentek announce its intention to market ZenGUARD™ as a Class I medical device?
