eudamed_udi Primary ID: 07290008960359

smartheart (UDI 07290008960359)

Manufactured by SHL Telemedicine International Ltd.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The smartheart (Model/Catalog Number: E-467-X) is a medical device manufactured by SHL Telemedicine International Ltd.. This product is indexed under FDA Product Code / Category Classification Z12050803 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: E-467-X
Product Code / EMDN: Z12050803
Device Name: smartheart
Database Sync Date: 2026-08-09 17:00:10

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of smartheart?

The registered manufacturer of record for smartheart is SHL Telemedicine International Ltd..

What is the Primary UDI-DI identifier for smartheart?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07290008960359.

What classification code is assigned to this device?

This device is registered under product classification code Z12050803.

Similar Classification Devices (Z12050803)

Other Devices by SHL Telemedicine International Ltd.

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