SYDNEY: Wellfully Limited (ASX: WFL) announced that the Swisswell Lubricen Knee Patch has been successfully registered as a Class I medical device in the EU, effective April 11th, 2022.
The Swisswell Lubricen Knee Patch has achieved notification and registration with EUDAMED as a Class I medical device in the European Union.
Registration as a Class 1 medical device enables substantiated medical claims to be made, substantially enhancing roll-out opportunities with pharmacy partners across the EU markets and strongly augmenting the existing cosmetics device registration.
The EUDAMED registration serves as a platform for similar product registrations across other markets including the US, UK and Australia.
The Swisswell Lubricen Knee Patch was initially launched in August 2021, but only sold through the Company’ DTC (direct-to-consumer) channels. Initial feedback from consumers, and as well interest from potential industry partners, has been very positive.
A number of initial collaboration evaluations have been initiated across several markets through to December 2021.
With this registration the Company will now be able to execute on existing collaborations, as well as engage with new partners and distributors across the EU markets. This can now be done on a wider scale (in terms of both marketing and distribution) as compared to the cosmetics device registration awarded January 2022.
Importantly, the medical registration allows for substantiated pain relief claims to be made by both the Company and its specialist retailers (esp. pharmacies).
The Company will use the EUDAMED registration, as well as the earlier CPNP cosmetics device registration, to support necessary regulatory approvals in other important markets such as the US, the UK and Australia.
Wellfully is a fully integrated, science-based wellness company. In addition to our own-brands, RÉDUIT and SWISSWELL, we also offer a portfolio of proprietary technologies and support partners by providing IP and expertise in magnetic array design, feasibility and efficacy, and claims testing, engineering and production.