Shenzhen, China | Oct. 25. 2017
Warp United Scientific Co. Ltd., a Chinese Health 2.0/Point-of-Care Solution developer and manufacturer, today announced that the Company successfully completed its final CE Mark audit meeting. The review of the Company's Warp 3 Medical Recorder was conducted Oct. 22-24, 2016 by SGS S.A. a Swiss based multinational testing and certification firm. This audit is required to demonstrate compliance with the regulatory requirements to achieve CE Mark approval.
Kilo LIANG, MD, Warp United CEO and Co-Founder, stated, "We're extremely satisfied to have finished our confirmation audit of the Warp 3 Medical Recorder at the Company's Shenzhen based home office and outsourced manufacture facility. Our in-house improvement group, alongside a few representatives from our world class supplier, contributed productively amid this procedure because of the immeasurable ability in R&D, manufacture, clinical research, administrative, and quality."
Kilo further stated, "Upon effectively finishing this audit, the CE certificate would for the most part be relied upon to be issued preparing to the future marketing of the Warp 3 Medical Recorder in the EU and different regions which acknowledge the CE mark."
Previously on July 30, 2016, the Company had successfully received test certification of compliance for Warp 3 Medical Recorder from SGS S.A., a Swiss based multinational testing and certification firm. Compliance testing included electrical safety testing for US, Canada and the European Union.
Dr. George WU, MD, Warp United CMO, commented, "I'm extremely pleased with our group and how they arranged for and dealt with this vital occasion. Together, we have spent countless hours in reckoning of meeting with delegates of SGS. In spite of the fact that a date has not been clarified for the receipt of the CE certificate or the launch of the product, we trust we stay well on our approach to finishing the last administrative stride during the time spent accomplishing CE Marking."
Warp 3 Medical Recorder is not yet CE marked or FDA cleared and is not yet commercially available.
About Warp United
Warp United is a point-of care solution company focused on the development and commercialization of handheld solution, software and hardware, to help doctors to provide medical service. Founded in 2013, situated in Shenzhen, China, by Kilo LIANG, MD and Dongdong Zheng, MD, Warp United is led by experienced experts in the medical device and practice. The Company’s first certified and commercially available product is Warp 3 Medical Recorder, a multi-purpose point-of-care solution with vital sign and ultrasound.
