Eu Mdd Eu Md Class 2b On The Market ๐Ÿ‡จ๐Ÿ‡ณ China

Semi-automatic external defibrillator

Ambulanc(Shenzhen)Tech.Co., Ltd. ยท ๐Ÿ‡จ๐Ÿ‡ณ China
Devices (same UDI-DI)
1
Certificates
1
Countries
4
Notified Bodies
1

Basic Information

Primary DI
06970658140646
Basic UDI-DI Code
B-06970658140646
Reference
204
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

AED is a kind of medical electronic equipment that uses electric shock to treat arrhythmia patients. It has the advantages of high curative effect, quick action, simple operation and non-invasive.The widely accepted view of electric shock defibrillation is that, under the action of electric field formed by discharge, a sufficient number of cardiomyocytes are forced to depolarize and enter the refractory period at the same time, so that the wave front of ventricular fibrillation cannot continue to propagate and the original chaotic electrical activity is suppressed.The heart muscle then returns to normal rhythm, driven by spontaneous excitation of the sinoatrial node.The mode of action can be simply described as: "A treatment in which a strong pulse of controlled energy is administered to the human heart to eliminate arrhythmias and restore sinus rhythm." The electrophysiological basis of defibrillation technique is that the phase of activity of each part of the myocardium is not synchronized, and the arrhythmia is sustained due to the back and forth transmission of excitement. The ultimate purpose of electric shock is to force the whole heart to enter the depolarizing state immediately, to realize instant cardiac arrest, and to restore synchronization of the activity phase of each part of the myocardium. After electric shock, the sinus node with the highest automaticity may be awakened to repace the heart, control the heart beat, and restore it to normal sinus rhythm.

CND Nomenclature Codes

Code Description
Z12030503 AUTOMATIC DEFIBRILLATORS

Certificates

Type Number
MDD Annex II (excluding section 4) CE 705577

Available In Countries

๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands

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