EC-12S V6

Organization name

LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.

SRN

HU-MF-000002846

Manufacturer status

Active

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• 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

05999883490259

Basic UDI-DI

5999883490ECGSRY

Reference / catalog number

EC-12S 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 ECG device with the attached Software connected to a PC, builds a 12-Channel Stress Test ECG system combined with BP measurement function based on auscultation principle. There is need for a loading device, but there is no need for external blood pressure monitor, because this device has its own, built-in one. Such kind of examinations typically takes about 15-20 minutes. 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 patient has to do some exercises on a loading device (ergometer or treadmill) or a pre-defined stress exercise test protocol (6 minute walking test) in order to significantly increase his heart rate.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification