Australia TGA ARTG record

Electrocardiographic lead, single-use

Australia TGA ARTG Registered Device · Meditech Systems Asia Pacific Pty Ltd · Shenzhen Medke Technology Co Ltd · Class I · Started July 04, 2024

Good Name: Meditech Systems Asia Pacific Pty Ltd - Electrocardiographic lead, single-use

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 04, 2024
Effective Date: July 04, 2024

Sponsor

Name: Meditech Systems Asia Pacific Pty Ltd

Manufacturer

Name: Shenzhen Medke Technology Co Ltd
Country: China
Address: 401 503 Bldg A1 Anle Ind Zone No 172 Hangcheng Rd Sanwei Community, Hangcheng Street, Baoan District, Shenzhen, 518126

Intended purpose

ECG (electrocardiogram) lead wires are intended for use on adult and pediatric patients within a hospital or medical facility, which provides patient care to monitor the electrical activity of the heart. These lead wires are single patient use.

About this record

Access comprehensive regulatory information for Electrocardiographic lead, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Meditech Systems Asia Pacific Pty Ltd, manufactured by Shenzhen Medke Technology Co Ltd in China. The device registration started on July 04, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.