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Basic Information
- Primary DI
- 05905358809006
- Basic UDI-DI Code
- B-05905358809006
- Reference
- M-TRACE
- 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 Electrocardiograph allows to record on thermal paper heart impulses in full range of 12 standard channels. The device is compact. It has small dimensions and a built-in battery. It allows to conduct examinations in all conditions. It is crucial for cardiologic departments as much as for family doctorโs job. The electrocardiograph is designed to perform ECG recordings on the entire human population - Pediatric electrodes should be used when performing tests on pediatric patients. The electrocardiograph is mainly intended for use in hospitals and doctors' 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
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