返回Dongguan Aidisy Electromechanical Equipment Co., Ltd. is a factory specialising in the production of nebulisers,
which was granted FDA 510K registration in the US during 2013. This is one of the nebuliser companies in the peer
group that was approved to enter the US early, so the company took the lead and gained a considerable sales market
in the US, adding a certain advantage for the US FDA certification.
Aidisy and Reanny Consulting had been in full co-operation for many years, and CE/ISO 13485/FDA 510K/FDA factory
inspections have always been counselled by Reanny Consulting. Having already passed the FDA factory inspections
during 2016, our solid partner still chose us for the re-inspection in 2019. After three months of perfect co-operation
and professional guidance, the hardware of the small company with around 50 employees should be for the level of
a first-class company.
During the FDA-certified factory inspection from 8 to 11 July 2019, the company passed the inspection with zero
defects and, due to perfect preparation, the audit process went smoothly and ended a day early. This created a new
record of counselling and consulting work for Reanny Medical Devices Management Consulting Ltd. in 2019! This
excellent result comes from our professional counselling at Reanny and the careful preparation of the client deserves
to be warmly celebrated.
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. will continue to work hard to provide customers
with professional counselling consulting, to provide you with professional U.S. FDA certification services!
