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PU Sensor - Pressure ulcer risk assessment analyser - ARTG 409689

Access comprehensive regulatory information for PU Sensor - Pressure ulcer risk assessment analyser in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 409689 and sponsored by Active Medical Supplies Pty Ltd, manufactured by PU Sensor AB in Sweden. The device registration started on May 26, 2023.

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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Class I
ARTG 409689
Class I
PU Sensor - Pressure ulcer risk assessment analyser
ARTG ID: 409689
Good Name: Active Medical Supplies Pty Ltd - PU Sensor - Pressure ulcer risk assessment analyser
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Intended Purpose

A device intended to be used by a healthcare professional to identify a patientโ€™s risk of developing pressure ulcers through the transcutaneous evaluation of pressure-induced vasodilation (PIV) of the skin. It primarily consists of a main unit, a body surface photoplethysmography sensor, and an inflatable cushion/pad that enables application of light pressure to a localized body area (e.g., sacral region).

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
409689
Start Date
May 26, 2023
Effective Date
May 26, 2023
Manufacturer
Country
Sweden
Address
Snickaregatan 40 582 26, Linkoping