EC-12H/ABP V6 System

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

05999883490570

Basic UDI-DI

5999883490HOLTERSR9

Reference / catalog number

EC-12H/ABP V6 System

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 combined device include the capabilities of ECG Holter Systems and EC-ABP blood pressure meter. It is able to record ECG signals and blood pressure measurement results at the same time. The device is intended to acquire, record and store up to even 48 hours of ECG data and BP readings of patient. The Cardiospy software provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Beside that they compute accurate and comprehensive systolic and diastolic readings, heart rate, mean arterial pressure, BP load and pulse pressure. Easily configured and individually-fitted for each patient by a physician or health care professional. The SpO2 value measured by the connected sensor is displayed on the control screen Measurements are automatically captured, without medical supervision and later downloaded to a computer for analysis and interpretation by a physician.

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.

• Z12050402MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)