Eu Mdd Eu Md Class 2b On The Market 🇨🇳 China

Automated External Defibrillator

Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1

Basic Information

Primary DI
06973107240089
Basic UDI-DI Code
B-06973107240089
Reference
PowerBeat X3
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

The PowerBeat Series Automated External Defibrillator (hereinafter called “PowerBeat Series Defibrillator”) is a portable device that is mainly used for first aid on patients with ventricular fibrillation (VF) which is the most common cause of sudden cardiac arrest(SCA), and certain ventricular tachycardias (VTs). It consists of a host, a non-rechargeable battery and disposable defibrillation pads. Depending on the different display, there are two models, PowerBeat X1 and PowerBeat X3, X1 uses LED light, graphic panel and voice prompt to guide the operator, while X3 uses color display, voice, animation and text prompt.

CND Nomenclature Codes

Code Description
Z12030503 AUTOMATIC DEFIBRILLATORS

Certificates

Type Number
MDD Annex II (excluding section 4) G1 107512 0002

Available In Countries

🇦🇹 Austria 🇩🇰 Denmark

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