Devices (same UDI-DI)
1
Certificates
1
Countries
31
Notified Bodies
1
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
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐ฌ๐ง United Kingdom
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