Manufactured by
Shenzhen, Guangdong, China
Shenzhen Kentro Medical Electronics Co., Ltd. Founded in May 2013, we are a private high-tech enterprise specializing in the design and development, production and sales of medical devices and healthcare products. We have an advanced integrated production center with the whole industry chain, such as injection molding, screen printing, SMT connectors and product assembly. All products are independently designed and developed and have a number of invention patents, software copyrights and other intellectual property rights. The products are equipped with the latest electronic technology, have exquisite design, are safe and reliable, and are unanimously praised by customers for their high quality, low price and excellent service. Over the years, we have paid attention to the actual needs of customers and established an innovative and flexible R D team. The company relies on YY/T0287-2017 IDT ISO13485:2016, EN ISO13485:2016 Medical device quality management system for regulatory requirements , EU Medical Device Directive MDD 93/42/EEC, Canadian Medical Device Conformity Assessment Regulations CMDCAS13485, US FDA QSR820 regulations, China CFDA Medical Device Manufacturing Quality Management Regulations and related regulations, in conjunction with the actual situation of the company and product characteristics, established a quality management system and obtained the Chinese Medical Device Product Registration Certificate, Medical Device Production License, Measuring Device Manufacturing License, EU CE Medical Device Certificate, US FDA 510 (K) Certificate, CMDCAS13485 Certificate, etc. etc.
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