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Tear flow test strip - ARTG 399400

Access comprehensive regulatory information for Tear flow test strip in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 399400 and sponsored by Biotech Healthcare Australia Pty Ltd, manufactured by Bio-Tech Vision Care Pvt Ltd in India. The device registration started on November 14, 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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TGA ARTG Official Data
Class Is
ARTG 399400
Class Is
Tear flow test strip
ARTG ID: 399400
Good Name: Biotech Healthcare Australia Pty Ltd - Tear flow test strip
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Intended Purpose

Bio Schirmer Ophthalmic Strips is indicated for the measurement of production of tear and its volume for a dry eye test.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
399400
Start Date
November 14, 2022
Effective Date
November 14, 2022
Manufacturer
Country
India
Address
Plot No 555-556-557 Opp Subham Tex-O-Pack Khatraj-Vadsar Road PO Khatraj Taluka, Kalol Dist, Gandhinagar, Gujarat