Automatic external defibrillator belongs to several classes of medical devices

Summary: The automated external defibrillator belongs to Class III medical devices, Class III medical devices are the highest level of medical devices, but also must be strictly controlled medical devices, refers to the implantation of the human body, used to support, life-sustaining, the safety and efficacy of which must be strictly controlled medical devices. Automated External Defibrillators (AEDs) are used primarily in public **** settings and are designed for use by untrained non-medical personnel. Specific automated external defibrillator belongs to several categories of medical devices and automated external defibrillator application occasions, together to the text to see it! First, the automatic external defibrillator belongs to several categories of medical devices

Automatic external defibrillator belongs to the management of class III medical devices, classification code 6821 medical electronic instruments and equipment, in order to sell it must have a class III license (city council for), to have a sales related management system as well as the system, after-sales service and so on.

Automatic external defibrillator business, the specific processing information is as follows:

1, submit the application form for a medical device business license, signed by the legal representative or stamped with the official seal of the enterprise.

2, industrial and commercial administration issued by the business name pre-approval documents or "business license" copy and proof of the original

3, the person in charge of quality management of the enterprise's identity card, academic or professional title certificate copy and biography. Quality management personnel's identity card, education or title certificate copies.

4, business premises, warehouse location map, floor plan (indicating the area), proof of ownership of housing or a copy of the lease agreement.

5, enterprise product quality management system documents and storage facilities, equipment catalog.

6, for the three types of medical devices business license content includes the need for refrigeration of drugs, the enterprise has the transport equipment, storage facilities and equipment table.

Second, what are the applications of automated external defibrillator

China's annual 544,000 people died of cardiac arrest, most of these accidents occur outside the hospital, due to the objective situation can not be timely rescue.

China's government is also vigorously promoting first aid training for the public, as well as the deployment of automated external defibrillators (AEDs) in public ****places, with the aim of enabling more people to receive timely first aid in the event of an accident.

Automated external defibrillators (AEDs) are used to resuscitate patients in the event of cardiac arrest, and are currently mainly used in first aid in public ****ing settings. Its function and operation are designed primarily for use by untrained non-medical personnel.