“Bioneb has the potential to change the future of medicine, others can only dream of “
Nick Havercroft – CEO & Founder Bioneb
Bioneb Limited Trademarks, Patents and Approvals
The IP has been approved in the USA, China and is pending for the EU and the rest of the world in the name of Bioneb. The patents for the juice formulations are in the process of being patented and will belong to Nicholas Havercroft-Bioneb Ltd. for the USA, Asia Pacific, EU and rest of the world.
Analytical data (i.e. full aerosol size distributions across multiple batches, and delivered dose data across multiple puffs and multiple devices): Bioneb, and the manufacturer have in house data for medication aerosol performance verification and validation test report for the delivery device. We use the same technology in the newly modified exterior shell of the various devices. Eighteen (18) test reports were submitted to obtain the 510K for FDA and CE approval.
The factory of manufacturer is FDA approved, one of only two in Asia Pacific : GMP, FMEA, strict quality control, CE and 510K approval were obtained for the ultrasonic vibrating mesh device and all of Bioneb proposed devices use the same technology with different outer shell designs
RoHs and REACH approval obtained for delivery device and materials. The same materials are being used for all Bioneb devices.. RoHs and REACH approval will be obtained similarly prior to mass production
The mesh plate is made of platinum in a patented process. This is unique and superior to our competitor’s plastic and stainless steel mesh which breaks down and produces toxic substances over time. Our mesh design and composition are ultrafine, strong and stable.
FDA certified manufacturing facility with ISO 13485, CE 0197, CE 0537 FDA 510K approvals. Three lines currently operation for manufacture with ample space for expansion. Current capacity 300,000 units per month per line. Ready for production immediately..