Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 05905358809037
- Basic UDI-DI Code
- B-05905358809037
- Reference
- M-TARCE mobile
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- M4Medical Sp. z o.o.
Additional Description
M-TRACE MOBILE is a recorder designed for remote recording of ECG waveforms. The recorder is characterized by a compact design, small dimensions and internal power supply. It communicates with a computer/tablet via Bluetooth. The device can be used both at rest and during endurance training as part of cardiological telerehabilitation
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12050301 | GENERAL PURPOSE ELECTROCARDIOGRAPHS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | HD 1497993-1 | TÜV Rheinland LGA Products GmbH | Expired |
Available In Countries
🇵🇱 Poland
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