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(Sharecast News) - Infection prevention products developer Tristel announced the successful conclusion of all reviews required under the UK and European Union medical devices regulations for the approval of its TANK ClO2 sporicidal disinfectant system on Monday.
The AIM-traded firm said that resulted in a positive recommendation for UKCA and MDR certification.
It said the TANK system, along with its accompanying capsules, was the latest addition to its Cache range, which offers sporicidal surface disinfection in a sustainable format, providing an alternative to commonly used pre-wetted plastic wipes.
With the attainment of MDR approvals, Tristel said it would ramp up sales efforts for the TANK system across Europe and in regions recognising products conforming to the stringent standards of the new EU MDR.
The company's directors anticipated that the approval would unlock significant growth opportunities for the Cache product range, particularly in the relatively untapped sporicidal surface disinfection market.
Tristel said it aimed to officially launch the products in Europe before the current financial year ends on 30 June.
In the financial year ended 30 June 2023, revenues generated from the Cache range amounted to £3.3m, constituting 9.2% of the company's total annual turnover.
"Whilst our Cache product range is intended for environmental surfaces, many of the surfaces in a hospital setting are considered medical devices and so it is key for any disinfection products to comply with the new EU medical device regulation," said chief executive officer Paul Swinney.
"It is a very significant achievement to have concluded all reviews successfully and we expect to receive our recommendation for certification from our Notified Body very shortly.
"Conformity with MDR will allow us to apply CE marking to these new products and gives us the opportunity to deliver significant growth in sales of the Cache product range going forward."
At 1150 GMT, shares in Tristel were up 6.67% at 480p.
Reporting by Josh White for Sharecast.com.
