Striate+™ re-certified under new European medical device regulations

24 August 2023
Posted in Company News
24 August 2023 Orthocell

Orthocell has announced that Striate+™dental membrane has received regulatory approval under the new European Medical Device Regulations (MDR).

Striate+ originally gained EU regulatory approval in 2017, but was required to be re-certified under MDR to be legally sold in the 30 European Economic Area member countries. Recertification allows continued sales of Striate+ in all 30 European Economic Area member countries. 

Orthocell Managing  Director,  Paul  Anderson, commented:

“Re-certification to the MDR is a significant milestone for the Company as it confirms Striate+, manufactured by the Company in Western Australia, complies with the more stringent safety and efficacy standards now in place in the EU. Additionally, it enables BioHorizons, our marketing and distribution partner, to continue to execute their plans to enter the EU market without restriction. We look forward to working with BioHorizons to launch Striate+ in the EU and expand into multiple EU countries.”

Click here to read the ASX release.