M-TRACE PC
Basic Information
- Primary DI
- 05905358809013
- Basic UDI-DI Code
- B-05905358809013
- Reference
- M-TARCE PC
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- M4Medical Sp. z o.o.
Additional Description
The M-TRACE PC recorder in conjunction with the M-Trace PC BASE application is a device designed to record ECG waveforms in the full range of 12 standard leads. The recorder is characterized by a compact design, small dimensions, and internal power supply. It communicates with the computer via a wireless connection in the BLUETOOTH standard or a USB wired connection - this allows for easy testing. The electrocardiograph is designed to perform ECG recordings on the entire population of people - when performing tests on pediatric patients, pediatric electrodes should be used. The electrocardiograph is primarily intended for use in hospitals and doctor's offices.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12050301 | GENERAL PURPOSE ELECTROCARDIOGRAPHS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | HD 1497993-1 | TรV Rheinland LGA Products GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).