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Speculum, vaginal, single use - ARTG 467525

Access comprehensive regulatory information for Speculum, vaginal, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 467525 and sponsored by Sonita Medic Enterprises Pty Ltd, manufactured by Taizhou Kangjian Medical Equipment Co Ltd in China. The device registration started on November 06, 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 Is
ARTG 467525
Class Is
Speculum, vaginal, single use
ARTG ID: 467525
Good Name: Sonita Medic Enterprises Pty Ltd - Speculum, vaginal, single use
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Intended Purpose

Vaginal Speculum with Smoke Extractor - various sizes (STERILE SINGLE USE). Single Use Vaginal Speculum intended to be used during examination and treatment of the vagina for the purpose of providing access to the interior, usually by expanding / distending the opening to the orifice. Design for use with loop diathermy.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
467525
Start Date
November 06, 2024
Effective Date
November 06, 2024
Manufacturer
Country
China
Address
The Machine Electricity Zone Hang Ni Kan of Yuhuan County, Zhejiang Province, 317600