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Cuff, blood pressure, single use - ARTG 448548

Access comprehensive regulatory information for Cuff, blood pressure, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 448548 and sponsored by Tenacore Pty Ltd, manufactured by Shenzhen Medlink Electronics Tech Co Ltd in China. The device registration started on May 14, 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.

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TGA ARTG Official Data
Class I
ARTG 448548
Class I
Cuff, blood pressure, single use
ARTG ID: 448548
Good Name: Tenacore Pty Ltd - Cuff, blood pressure, single use
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Intended Purpose

The NIBP Single-Use Cuffs are designed for measuring arterial blood pressure non-invasively in adults, children, and neonates. These disposable cuffs are intended for single-patient use and are suitable for use in various healthcare settings, including hospitals, clinics, and during transport within healthcare facilities. The cuffs are compatible with a range of automated blood pressure monitoring devices and are designed to reduce cross-contamination risks between patients. These cuffs are made of biocompatible materials that ensure patient comfort and safety during the measurement process. The product is specifically intended for use as part of a blood pressure monitoring system, providing accurate systolic, diastolic, and mean arterial pressure readings through the oscillometric method. The cuffs are available in multiple sizes to accommodate a wide range of patient limb circumferences and are designed for ease of use by healthcare professionals to ensure efficient workflow and patient care.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
448548
Start Date
May 14, 2024
Effective Date
May 14, 2024
Sponsor
Manufacturer
Country
China
Address
4th Floor Building A Ying Tailong Industrial Park Dalang South Road, Longhua District, Shenzhen, 518109