News and Announcements
Rapid Response Revival receives regulatory approval to sell its first product, the automated external defibrillator branded as CellAED®, in Europe
- Published May 19, 2021 12:00AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
Rapid Response Revival Research Limited is pleased to announce that its subsidiary, RRR Manufacturing Pty Ltd, has received notification that the CellAED® v2.2 has met the requirements of the European Union CE Directive as a Class IIb medical device.
This is a significant milestone for RRR and is a foundation for the work ahead. We are looking forward to continued successes as our business grows. Further updates including our Clinical progress and the opening of RRR’s next capital raising efforts will follow as news is available.
About CE: The attainment of certification is a valuable third-party validation of the CellAED®. Establishing the CellAED® meets the same standards required of existing AEDs available to the European market. CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. The initials “CE” do not stand for any specific words but are a declaration by the manufacturer that the product meets the requirements of the applicable European Directive(s). CE marking is required for market access to countries forming the EU as well as Norway, Iceland & Liechtenstein, Switzerland. In all 33 countries require the Mark and may be accepted in other jurisdictions at their discretion.
About Rapid Response Revival Research
Rapid Response Revival are the innovators behind the CellAED® defibrillator technology – transforming everyday people into heroes.
Sudden Cardiac Arrest (SCA) has an extremely high death rate and is a leading cause of death globally, accounting for more deaths than many cancers, influenza, car accidents and house fire deaths combined. Anyone can suffer from SCA, regardless of age, gender or fitness level – including children. The current survival rate is just 2-11%.
Rapid Response Revival Limited seeks to improve the survival rate of SCA by making fast treatment effective, simple and affordable – restarting hearts in cardiac arrest within the critical ‘Survival Gap’ (first 4 minutes) before emergency services arrive. This increases the survival rate of SCA victims who receive defibrillation within this ‘Survival Gap’ as high as 70% and helping to bridge the gap to professional care.
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