Eu Mdd Eu Md Class 2b On The Market 🇭🇺 Hungary

CA-1 AED Semi-automatic defibrillator

Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1

Basic Information

Primary DI
D-CA-1AEDEH
Basic UDI-DI Code
B-CA-1AEDEH
Reference
KCA1B
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

The CardioAid®-1 AED defibrillator is an instrument serving for stopping the ventricular fibrillation; it can change the electric operation of the heart, by applying a high energy impulse. The device has LOW ENERGY BIPHASIC TRAPEZOIDAL EXPONENTIAL (BTE) WAVEFORM with patient impedance compensation up to [200-270 J] to shock all VF and VT arrhythmias. Additionally the device supports an extra high [360 J] biphasic energy selection feature for unusual, irregular circumstances in case of overweight patients without causing any additional damage of heart muscle that is a safe additional energy option for the physician to improve the successful of the defibrillation. In defibrillation mode the device performs Innomed Biophase®, biphasic output rectangular waveform. The CardioAid®-1 AED can be used with an optional CPR module – called Innomed CPR module. The CPR module has been developed to give efficient assistance to the doctors, first-aid trainers, resuscitation instructors, untrained NHS employee and bystanders. The unit controls and gives audible voice prompts about the quality of CPR performed by the operator. So the Innomed CPR module is an extremely useful device either is used for student educational purposes.

CND Nomenclature Codes

Code Description
Z12030501 SEMI-AUTOMATIC DEFIBRILLATORS

Certificates

Type Number
MDD Annex II (excluding section 4) HU19/8463

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

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