Shenzhen JUMPER Company is a professional manufacturer specializing in the research and development, sales, and production of medical devices related to women and children. Its products include thermometers, blood pressure monitors, stimulators, fetal heart rate and monitoring, blood oxygen, and other products. The product has been sold to the Chinese, European, and American markets, and there is a strong desire for FDA 510K certification in the United States.As a global consumer of sensitive words, the United States also has a high usage of medical devices. According to statistics from relevant institutions, the medical device market in the United States in 2017 was one trillion US dollars (compared to one trillion Chinese yuan), while there are less than 500 domestic medical device manufacturers and operators in the United States. So the medical equipment in the United States heavily relies on imports. As a factory base for sensitive words in the world, China presents a great opportunity for medical device manufacturers.In 2018, JUMPER once again chose Rui Enni Consulting as a trusted partner as the registration agent for FDA 510K certification in the United States. The wireless continuous body temperature patch of this customer is a relatively new application product in the market, and there are mainly the following difficulties:1) The measurement site, aside from the traditional armpit, chose to measure the temperature of the left chest;2) Measurement time, 24-hour continuous monitoring;3) Transmission method, customer developed app using wireless BLUETOTH transmission technologyWith professional guidance and document preparation from Ruini Consulting, we obtained the 510K certification approval from the US FDA in 2019. The K number is K182437. In cooperation, Rui Enni Consulting always provides customers with more services, and professionalism and service are the foundation of the consulting company's operation.

Dongguan Aidishi Electromechanical Equipment Co., Ltd. is a professional factory that produces atomizers and obtained FDA 510K registration in the United States in 2013. This is one of the atomizer companies that was approved to enter the United States early among peers, so the company has taken the lead and gained a considerable sales market in the United States, adding a certain advantage to the FDA certification in the United States.Aidi Shi and Rui Enni Consulting have had a comprehensive cooperation for many years, and CE/ISO 13485/FDA 510K/FDA factory inspections have always been guided by Rui Enni Consulting. We have already passed [sensitive word] FDA factory inspections in 2016, and in the 2019 re inspection, our stable partner still chose us. Under three months of perfect cooperation and professional guidance, a small company of about 50 people should have hardware that meets the level of a first-class enterprise.During the factory inspection for FDA certification in the United States from July 8th to 11th, 2019, the review was successfully passed with zero defects, and due to the perfect preparation, the audit process was very smooth and ended one day ahead of schedule. This has set a new record for the coaching and consulting work of Ruini Medical Device Management Co., Ltd. in 2019! This outstanding achievement comes from our professional coaching at Ruini Company and the careful preparation of our clients It is worth celebrating warmlyShenzhen Ruienni Medical Device Management Co., Ltd. will continue to work hard and provide professional counseling and consultation for customers, as well as professional FDA certification services for you!

Shenzhen Teweike is a professional manufacturer specializing in the research and development, production, and sales of medical bioelectronic instrument accessories and consumables. Located in the beautiful coastal city of Shenzhen in southern China, it designs and produces supporting products for various blood oxygen monitors, electrocardiogram monitors, electrocardiographs, electroencephalographs, temperature monitoring devices, B-ultrasound machines, fetal monitoring devices, non-invasive blood pressure monitors, invasive blood pressure monitors, surgical series instruments, workstations, central monitors, and electrocardiogram telemetry systems; At the same time, we also produce lead wires and accessories for other comprehensive treatment devices such as health, beauty, and physical therapy.During the 2018 CE technical document annual review, the company's CE technical documents were identified by auditors as a series of serious non conformities. After being introduced by a friend, both parties entered into a contract.The key challenge of this rectification lies in the clinical performance testing report. With professional ability and without increasing the cost of the enterprise, Rainey successfully resolved the issues raised by the auditor in compliance and legality, and passed the CE rectification smoothly.This is just the beginning of a collaboration, and it is also one of the many CE coaching cases for Shenzhen Ruinni. With professional regulatory capabilities and enthusiastic service attitude, Ryan Ni has once again gained recognition from customers.

FDA certificationShenzhen Alicn is a professional manufacturer specializing in the research and development, sales, and production of active medical devices, including thermometers, blood pressure monitors, stimulators, laryngoscopes, and other products. The product has been sold to the Chinese and European markets, and is actively developing the US market.As a global consumer of sensitive words, the United States also has a high usage of medical devices. According to statistics from relevant institutions, the medical device market in the United States in 2017 was $100 billion (China's medical device market was $100 billion), while there were less than 500 domestic medical device manufacturers and operators in the United States. So the medical equipment in the United States heavily relies on imports. As a factory base for sensitive words in the world, China presents a great opportunity for medical device manufacturers.Alicn prepared for the 510K registration of infrared thermometers and wireless printed arm blood pressure monitors in 2018. For the registration of wireless printed arm blood pressure monitors, both wireless and printing are significant challenges. After internal expert consultation, Ruini has made a detailed plan for wireless security, wireless coexistence, and security assessment.Successfully obtained FDA certification 510K approval in November 2018 and January 2019, with K numbers K180207 and K180435. After obtaining the K number, based on the customer's request for help, our company also assisted the customer in completing the product registration and listing work free of charge.

JKH Company is a professional manufacturer of active therapeutic devices for physical rehabilitation. The company's products are widely sold worldwide, mainly [sensitive words].Based on the demand of the Canadian market, the company applied for the MDSAP multi country certification program after passing the FDA factory inspection last year.This company's MDSAP certification covers the scope of all current member countries (the United States, Canada, Australia, Brazil, and Japan).With comprehensive guidance from our company and good foundation and cooperation from our clients, we have successfully passed the ten working days of review by the announcement agency. Finally, the MDSAP certification audit was passed with defect results of level 0.5, level 0.4, and a small number of level 3. This is a major cooperation project between the two parties for three consecutive years since the establishment of cooperation in 2016. Based on mutual recognition and trust between both parties, supplemented by their respective professional skills and expertise, they have repeatedly passed major audits and certifications.In the future, both parties will establish even closer cooperation, and customers will flourish like tigers!

Shenzhen ROUNDWHALE Company is a newly established enterprise specializing in the production of electrical stimulators such as TENS, EMS, IF, etc.    Due to our general consultant's extensive experience in the stimulator industry, the client's company packaged all the CE, FDA, domestic registration, and system establishment projects for the company's products and entrusted them to our company for guidance at the beginning of its establishment.DNV is a third-party certification body in Norway, known for its meticulousness and strictness in the certification industry.This is also our company's first case of participating in DNV certification consultation. In the early stage, we sincerely communicated with DNV about the CE TCF certification requirements, and quickly completed the CE technical documents with our professional abilities and expertise.During the initial CE review, the reviewing teacher provided high praise for our technical documents and directly submitted them for review abroad.After a round of communication and rectification, we quickly obtained DNV's CE approval. The pre - and post cycle does not exceed three months, and DNV sent congratulations claiming that this CE certification we have tutored has broken its record for fast certification cycles in the past two months.This is an honor and pride, as well as an encouragement.