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Congratulations to JUMPER for obtaining US FDA 510K clearance for the first electronic thermometer for continuous measurement of the left chest
Shenzhen JUMPER is a professional manufacturer specialising in the research, development, sales and production of medical devices for women and children, including thermometers, sphygmomanometers, stimulators, foetal heart and fetal monitoring, blood oxygen and other products. The products have been sold to China, Europe and the United&nb···
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Good News: Re-signing of Brazilian BGMP Counselling and Brazilian Medical Device Registration with Aidisy
Reanny consulting and Aidisy since the establishment of cooperation in 2014, Reanny had helped Aidisy to complete the CE, FDA, domestic registration and complete the FDA factory inspection and technical guidance, in the long-term cooperation to establish a long-term friendly and trustworthy friendship, get highly praised, to help the enterprise cul···
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Another success: OTC and Prescription Dual Use Integration Application Project Deficiencies Passed
The OTC and Prescription FDA 510K Dual-Use Integration Application project submitted by Shenzhen Reanny Medical Device Management Consulting Co. on 1 August 2019 achieved zero-defect clearance on 1 November 2019, with a full 3-month timeframe from submission to clearance. This is our fourth case in two years to receive a zero-defect clearance for 5···
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CE certification another success - zero defects through the audit
In September 2019 the customer was eager to sell during the conversion of MDD to MDR, we helped the customer to complete the update of the full set of CE technical documents for MDR infrared thermometer and ultrasonic nebuliser with high level, professionalism and efficiency. After the completion of the two sets of documents were submitte···
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Good news:Xiamen Weiyou Airwave Therapeutic Apparatus obtained CE certification
Good news--Xiamen Weiyou Airwave Therapeutic Apparatus obtained CE certificationCongratulations to Xiamen Weiyou Intelligent Technology Co., Ltd. for obtaining CE certificate for three models of airwave therapeutic instrument through SGS audit.
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Good news: ten registered certificates, six UDI applications, four Class I filings, three production licence applications
Congratulations to Dongguan Chengxin and Top Global for completing the CE marking of single-use medical masks. Goodhealth Electronic completed CE marking for arm sphygmomanometer and electronic thermometer with wireless function. Shenzhen Dongjilian's Airwave and Low Frequency Therapeutic Apparatus received FDA 510K approval. Dongguan Weir, Don···
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