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Bed, general-purpose, electrical

Access comprehensive regulatory information for Bed, general-purpose, electrical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Oceania Medical Technologies Pty Ltd, manufactured by Foshan Dahao Medical Technology Co Ltd in China. The device registration started on March 08, 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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Class I
Class I
Bed, general-purpose, electrical
Australia TGA ARTG Registered Device
Good Name: Oceania Medical Technologies Pty Ltd - Bed, general-purpose, electrical
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DJ Fang

DJ Fang

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Intended Purpose

A medical device designed to provide support and comfort to patients in healthcare settings. It includes electrically powered mechanisms for adjusting the height, position, and angle of the bed surface, as well as features such as side rails, braking systems, and control panels for patient and caregiver use. The bed is suitable for use in hospitals, clinics, and other medical facilities for patients. The product is suitable for diagnostic, therapeutic, or monitoring use in adult or paediatric patients under medical supervision, to support the patient's body and achieve clinically required positions. Normal operating conditions include a temperature range of 0ยฐC to 40ยฐC, relative humidity ranging from 25% to 90%, and atmospheric pressure between 86kPa and 106kPa. Electric hospital beds should not be placed near or stacked with other equipment. If it's necessary to place them close or stack them, it's important to observe and verify that they can operate normally in that configuration. Using accessories and cables other than those specified by the manufacturer of the electric hospital bed, except for cables sold as spare parts for internal components, may increase emissions or reduce the immunity to interference of the electric hospital bed. - To prevent patients from falling off the bed, please use the side rails. - When adjusting the angle of the bed surface, please pay attention to the patient's condition. - Please use the bed in the correct orientation. If the patient sleeps with the head or foot end of the bed reversed, improper posture may occur when adjusting the back or knee sections, leading to patient injury. - Do not install binding straps, as they may wrap around the body during back or knee elevation operations, potentially causing injury and damaging the bed. - When adjusting the bed, please be aware of walls and other obstacles. During height adjustment, the bed may move up, down, or forward, so ensure that there is no contact with walls or obstacles to prevent deformation or damage to the bed and surrounding objects. Make sure there is a distance of at least 20cm between the bed and the walls or obstacles. - When not moving the bed, always engage the wheel brakes to secure the bed. Unexpected injuries may occur to patients getting on or off the bed due to its movement.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 08, 2024
Effective Date
March 08, 2024
Manufacturer
Country
China
Address
Buidling 1 2nd of Building 2 3rd of Buidling 2 Buidling 3 4 5 6 7, No 9 of Fanye Road Leping town Sanshui District, Foshan City, Guangdong Province, 528137