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Speculum, vaginal, single use

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 sponsored by E & L May Pty Ltd, manufactured by Taizhou Kangjian Medical Equipment Co Ltd in China. The device registration started on April 29, 2022.

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 Is
Class Is
Speculum, vaginal, single use
Australia TGA ARTG Registered Device
Good Name: E & L May Pty Ltd - Speculum, vaginal, single use
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Intended Purpose

A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 29, 2022
Effective Date
April 29, 2022
Manufacturer
Country
China
Address
The Machine Electricity Zone Hang Ni Kan of Yuhuan County, Zhejiang Province, 317600