EC-3R/S V6

Organization name

LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.

SRN

HU-MF-000002846

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Hungary; available across 32 countries total.

Trade name

not provided

UDI-DI code

05999883490297

Basic UDI-DI

5999883490ECGSRY

Reference / catalog number

EC-3R/S V6

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

This device with the attached software provides a 3 channel Resting ECG or Stress Test ECG system. During an examination made by the Stress Test ECG system, the patient is examined for a short time (tipically less than an hour). During this time, the patient has to do some exercises on a loading device (ergometer, treadmill or master step) in order to significantly increase his heartrate. The stress devices are controlled by the Cardiospy software and the SpO2 value measured by the connected sensor is displayed on the control screen. The data evaluation is aided by the interpretation system of the software. This device is same with EC-12R/S V6 device but with limited channel number.

Additional information URL

https://www.labtech.hu/eifu/

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHS