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!

The OTC and prescription FDA 510K dual-use integration application project submitted by Shenzhen Ruienni Medical Device Management Consulting Co., Ltd. on August 1, 2019 was approved with zero defects on November 1, 2019, and took 3 months to be submitted for approval. This is our fourth case in two years to receive approval for 510K zero defects. This not only represents an honor, but also a strength. During 2019, we have continuously represented clients in submitting over 20 510K registration projects. Because of focus, it is professional; Excellence is due to professionalism; Because of excellence, leading.

Since the establishment of cooperation between Rui Enni Consulting and Ai Deshi in 2014, Rui Enni has helped Ai Deshi complete CE, FDA, domestic registration, as well as FDA factory inspection and technical guidance. In the long-term cooperation, a friendly and trustworthy friendship has been established, which has been highly praised. Rui Enni has helped enterprises cultivate professional talents and overcome difficulties. With the continuous growth and expansion of the enterprise's market, in November 2019, Ai Deshi and Rui Enni signed another Brazilian BGMP coaching and two sets of Brazilian medical device registration contracts. Brazil is an emerging market that is increasingly valued by the medical device market, and Rui Enni Consulting has been conducting in-depth research on the Brazilian market. Because of focus, it is professional; Because of professionalism, trust; Choosing because of trust; Because of the choice, it is also worthy of your trust.