Eu Mdd Eu Md Class 2a On The Market ๐Ÿ‡ต๐Ÿ‡ฑ Poland

M-TRACE PC

M4Medical Sp. z o.o. ยท ๐Ÿ‡ต๐Ÿ‡ฑ Poland
Devices (same UDI-DI)
1
Certificates
1
Countries
16
Notified Bodies
1

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
MDD Annex II (excluding section 4) HD 1497993-1

Available In Countries

๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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