返回Shenzhen Alicn is a manufacturer specialising in the research, development, sales and production of active class
medical devices, including thermometers, blood pressure monitors, stimulators, laryngoscopes and other products.
The products have been sold to China, Europe market, and is actively developing the U.S. market.
The United States as a global consumer country, the use of medical devices is also a global. According to the statistics
of relevant organisations, the U.S. medical device market in 2017 was 100 billion U.S. dollars (China's medical device
market is 100 billion RMB), while there are only less than five hundred U.S. local medical device manufacturing and
operating enterprises. So the United States relies heavily on imports of medical devices. China is the world's factory
base, so this is a very good opportunity for medical device manufacturers.
Alicn with the preparation of 2018 to carry out the 510K registration of infrared thermometer and wireless printable
arm sphygmomanometer. For the registration of wireless printing arm sphygmomanometers, both wireless and
printing are a big challenge. Reanny has planned in more detail for wireless security, wireless coexistence and security
assessment after internal expert consultation.
In November 2018 and January 2019, we successfully obtained the 510K approval from the US FDA, with the K
number of K180207 and K180435. After obtaining the K number, based on the customer's request for help, we helped
the customer to complete the registration of the product without any compensation.
