Production and sale of the paediatric safety harness for children in Sardinia, IUtaly
The device covered by this technical file is a new safety immobilization system for children, to keep them safe on the ambulance stretcher whenever a parent is transported who needs medical
intervention and cannot leave the child, or when the minor himself needs intervention and must be accompanied by a parent or guardian.
The harness is placed on the child and once in the parent's arms, is anchored to the ambulance stretcher, ensuring stability during transport in absolute safety. There is no other system like it in the country.
This medical device meets the requirements set forth by Regulations 2017/745/EU and 2017/47/EU and the Medical Devices Directive Law 93/42/EEC.