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Analgesic TENS system

Access comprehensive regulatory information for Analgesic TENS system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Compliance Management Solutions, manufactured by Shenzhen Kentro Medical Electronics Co Ltd in China. The device registration started on October 03, 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 IIa
Class IIa
Analgesic TENS system
Australia TGA ARTG Registered Device
Good Name: Compliance Management Solutions - Analgesic TENS system
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DJ Fang

DJ Fang

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Intended Purpose

Ellune (KTR-2302) is a TENS device for the temporary relief of menstrual pain and discomfort for primary dysmenorrhea, when the pain associated with menstruation is not caused by any underlying gynaecological disorder.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 03, 2023
Effective Date
October 03, 2023
Manufacturer
Country
China
Address
No 11 Shanzhuang Road Xikeng Village Yuanshan Street Longgang District, Shenzhen City, Guangdon Province