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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 I is sponsored by Hallmark Surgical Ltd, manufactured by Yuhuan City Shengbo Mould Manufacturing Co Ltd in China. The device registration started on May 14, 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
Speculum, vaginal, single use
Australia TGA ARTG Registered Device
Good Name: Hallmark Surgical Ltd - Speculum, vaginal, single use
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Intended Purpose

Speculum with in-built LED light for viewing the vagina and cervix, for diagnostic purposes. Disposable, and manufactured primarily from plastic.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 14, 2024
Effective Date
May 14, 2024
Sponsor
Manufacturer
Country
China
Address
317606 Yuhuan City, Zhejiang Province