The Tristel ULT foam for medical devices received FDA approval for use on endocavity ultrasound probes and skin surface transducers. Credit: Praisaeng / Shutterstock.com.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.”

See Also:

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

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
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.

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.