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Instrument/analyser IVDs

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Hurst & Co Pty Ltd, manufactured by Dainippon Seiki Co Ltd in Japan. The device registration started on January 15, 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
Instrument/analyser IVDs
Australia TGA ARTG Registered Device
Good Name: Hurst & Co Pty Ltd - Instrument/analyser IVDs
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Intended Purpose

This system automatically mounts sections of paraffin-embedded human tissue blocks(samples) to glass slides, which is usually performed manually for the preperation of human tissue sections used for histopathological diagnosis. It cenveniently automates the process from sectioning, transferring and mounting of the sections to the slides, then stretching and drying of the slides. The slides that this system prepares can be used for histopathological diagnosis after staining.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
January 15, 2024
Effective Date
January 15, 2024
Manufacturer
Country
Japan
Address
8 Tanatsugu Koutari Nagaokakyo, Kyoto, 6170833