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
- Manufacturer
- ViVest Medical Technology Co., Ltd.
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 | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 107512 0002 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
🇦🇹 Austria
🇩🇰 Denmark
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).
Horizontal Steam Sterilizer
Device
EU MDD
·
Eu Md Class 2b
·PROHS Equipamento Hospitalar e Serviços Associados S.A.·On the market·10 countries
Adacolumn
Device
EU MDD
·
Eu Md Class 2b
·JIMRO Co., Ltd.·On the market·9 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·8 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·7 countries
Sonovein
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·6 countries
Mevion S250i
Device
EU MDD
·
Eu Md Class 2b
·Mevion Medical Systems, Inc.·On the market·1 country