Shenzhen Rui Enni Medical Device Management Consulting Co., Ltd. and Shenzhen Nuobo Intelligent Manufacturing Technology Co., Ltd. have reached a cooperation consensus and signed an agreement on the international registration and system of medical device IPL photon hair removal device. Rui Enni Consulting will provide guidance on the Chinese NMPA, EU CE MDR, US FDA 510K registration and certification of Class II (IIa) medical device "IPL photon hair removal device", as well as the Chinese Medical Device Production Quality Management System Specification (GMP) for active devices, international integration system guidance for Japan JGMP, US QSR 820 and EU ISO 13485+MDR QMS, and clinical trial cooperation consulting services for IPL laser hair removal device. During this cooperation process, Rui Enni also provided services such as US company registration, American agent (US agent), production license agency, and UDI registration.Rui Enni is a professional medical device consulting enterprise in Shenzhen, Guangdong Province, which is one of the sensitive words for reputation and satisfaction. It is a professional consulting company that specializes in medical device regulation consulting, registration agency, quality management system establishment and improvement, enterprise management training and coaching, and clinical agency. It adheres to the reputation route of survival as a consulting institution! We grew up in the medical device industry, rooted in the medical device industry, and have a preference for the medical device industry. Our consulting plan will be more tailored to the actual situation of the enterprise and easier to implement and execute. Customers who have cooperated with us have unanimously praised us and established long-term consulting and agency partnerships!                       For medical device consulting services, seek advice from Ruini. We provide you with professional, systematic, comprehensive, and one-stop service enjoyment. During the contract process, Ruini can always provide you with more services and surprises!

Congratulations to Shenzhen Bairuiqi Medical Equipment Co., Ltd. for obtaining the domestic medical device registration certificate for non-invasive sleep ventilators. A non-invasive sleep ventilator is a device that can replace, control, or alter a person's normal physiological breathing, increase lung ventilation, improve respiratory function, reduce respiratory function consumption, and save cardiac reserve capacity. Mainly used in households to treat snoring, which leads to sleep apnea and hypopnea, and as a home sleep ventilator for treating chronic obstructive pulmonary disease and respiratory failure. After receiving the client's commission, our company learned the working principle of the product, familiarized ourselves with on-site operations, searched for a large number of domestic and foreign literature, maintained high communication with the client, and finally lived up to expectations and obtained domestic market approval.

Congratulations to Shenzhen Jingkehui Electronics Co., Ltd. for obtaining CE certification for two electrical stimulators, one of which is specialized in treating headaches and the other for treating dysmenorrhea and endometriosis; Among them, the infrared thermometer has passed CE certification, and there are many models of this product that can measure body temperature and surface temperature of objects; Among them, the air wave therapy device has passed CE certification. The product has a wide variety of types, expected uses, and functions. After strict audits by SGS 1639, it finally passed CE smoothly.For medical device registration and certification, look for Rui Enni, a professional medical device consulting service provider around you - dedicated for 14 years! Help you quickly obtain compliance certificates, accelerate product launch, and realize product value appreciation!

Congratulations to Dongguan Chengxin and Topu Global for completing the CE certification of disposable medical masks. Haokang Electronics has completed CE certification for arm blood pressure monitors and electronic thermometers with wireless functionality. Shenzhen Dongjilian's air wave and low-frequency therapy device has obtained FDA 510K certification approval. Dongguan Weier, Dongguan Lingyi, and Shenzhen Hengdeyuan have completed the second-class registration certificate and production license for disposable medical masks. Wenzhou Youshang's infrared forehead ear thermometer has obtained 510K approval through FDA certification. Four products of Guangdong Boyu Blue have completed Class I filing. Dongguan Chengxin, Huizhou Kaiyi, Shenzhen Yasikalo, Hong Kong Meicheng, Shenzhen Dongjilian, and Shenzhen Ruishengte have completed UDI application matters. Nine companies have completed their registration and listing in the United States!

Good news - Xiamen Weiyou air wave therapy device has obtained CE certificationCongratulations to Xiamen Weiyou Intelligent Technology Co., Ltd. for successfully passing the SGS audit and obtaining the CE certificate for three models of air wave therapy devices.

In September 2019, the customer was eager to sell during the conversion from MDD to MDR. We assisted the customer with a high-level, highly professional, and efficient update of the complete set of CE technical documents for MDR infrared thermometers and ultrasonic nebulizers. After completing the two sets of documents, they were submitted to SGS for review in early September 2019. In October, they passed the review with zero defects and were issued a new CE certificate to the customer.Efficiency comes from high professionalism. Rui Enni has been closely monitoring the dynamics of medical devices and staying at the forefront. Rui Enni never stops!