Pure Global

Cuff, blood pressure, reusable

Access comprehensive regulatory information for Cuff, blood pressure, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Ecomed Pty Ltd, manufactured by Spacelabs Healthcare Ltd in United Kingdom. The device registration started on August 10, 2021.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Cuff, blood pressure, reusable
Australia TGA ARTG Registered Device
Good Name: Ecomed Pty Ltd - Cuff, blood pressure, reusable
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Spacelabs Healthcare ABP Cuffs are intended to be used with Spacelabs Healthcare ABP devices for the non-invasive measurement of pediatric and adult human blood pressure and heart rate measurements for 24 hours to 7 days. The device shall be operated only by suitably competent personnel trained in the use and procedures of Ambulatory Blood Pressure monitors for diagnostic purposes.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 10, 2021
Effective Date
August 10, 2021
Sponsor
Manufacturer
Country
United Kingdom
Address
Unit B Foxholes Centre John Tate Road, Hertford, Hertfordshire, SG13 7DT