GENERAL PURPOSE ELECTROCARDIOGRAPHS

Primary DI

08800045800229

Basic UDI-DI Code

88000458HTPY5

Reference

Hativ P30A

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

VUNO Inc.

The device is intended to record, store, and transfer one-and two-channel electrocardiogram (ECG) rhythms, and analyze them based on an artificial intelligence(AI) algorithm. In single channel mode, Hativ P30 can record Lead-I. In two channel mode, Hativ P30 can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. Hativ P30 also displays ECG rhythm and output of ECG analysis including detecting the presence of normal sinus rhythm, atrial fibrillation or flutter, bradycardia, tachycardia, and others.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).