Tristel seeks regulatory approval for Tristel ULT disinfectant foam

Parker Laboratories, Tristel's North American business partner, will be responsible for manufacturing Tristel ULT.

Archana Rani September 05 2023

Infection prevention products manufacturer Tristel is seeking regulatory approval for its Tristel ULT hand-applied high-level disinfectant foam as a Class II medical device for endocavity ultrasound probes and skin surface transducers.

The company has submitted the Tristel ULT application to Health Canada and expects a decision early next year.

The Tristel ULT foam for medical devices received US Food and Drug Administration (FDA) approval in June 2023 for use on endocavity ultrasound probes and skin surface transducers.

Tristel CEO Paul Swinney said: “When we received our FDA approval for Tristel ULT in June, we set out for our shareholders our commercial strategy for North America. This included the submission to the Canadian regulatory authority of Tristel ULT during the current financial year and its approval before the end of H1 FY2025.

“I am pleased to report that we have accelerated our plans and can look forward to a commercial launch into the Canadian ultrasound market during our second half.”

Parker Laboratories, Tristel's North American business partner, will be responsible for manufacturing Tristel ULT.

The Tristel ULT is planned to be distributed through Parker's distributor network to ultrasound users in Canada.

Swinney added: “Parker Laboratories is well advanced in preparing to manufacture the Tristel foam disinfectants and we are on target to launch into the United States ultrasound market on or before 1 October 2023.”

Health Canada has already approved Tristel OPH, a high-level disinfectant for ophthalmic instruments, as a Class II Medical Device in 2021.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close