CHIS_001_B.1_Instructions for Use

Organization name

CARDIOHIS, S.L.

SRN

ES-MF-000046210

Manufacturer status

Active

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

• CW999

  Allergy to the adhesive used to affix the leads. CardioHis has not been clinically tested in patients under 18 years old and in pregnant women. Both groups of patients should be excluded from using the device.

Primary placement in Spain; available across 1 country total.

Trade name

not provided

UDI-DI code

08437026132002

Basic UDI-DI

8437026132001ZF

Reference / catalog number

CHIS_001_B.1_Instructions for Use

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

CardioHis is a medical device used to manually measure the left ventricular activation time (LVAT) parameter using ECG signals. CardioHis must be used ALWAYS in conjunction with a pacemaker programmer. CardioHis will be used ALWAYS to assist the physician in the study. The physician will NEVER make the final clinical decision using only the information shown on the CardioHis. CardioHis has not been clinically tested in patients under 18 years old and in pregnant women. Both groups of patients should be excluded from using the device.

Additional information URL

https://www.cardiohis.com/

Clinical sizes

No clinical sizes registered for this device.

• Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHS

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