Defibrillator/Monitor
Basic Information
- Primary DI
- 06944904028019
- Basic UDI-DI Code
- B-06944904028019
- Reference
- BeneHeart D3
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Additional Description
The equipment is intended for external defibrillation, internal defibrillation, synchronized cardioversion and semi-automatic defibrillation (AED). It can also be used for non-invasive external pacing as well as ECG, SpO2, PR, NIBP and CO2 monitoring. The equipment is for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation. The equipment is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030502 | MANUAL DEFIBRILLATORS |
| Z12030501 | SEMI-AUTOMATIC DEFIBRILLATORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 055 G1 044751 0166 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).