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Specimen receptacle IVDs

Access comprehensive regulatory information for Specimen receptacle IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Schiffa Health Pty Ltd, manufactured by Shandong Chengwu Medical Products Factory in China. The device registration started on August 31, 2021.

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
Specimen receptacle IVDs
Australia TGA ARTG Registered Device
Good Name: Schiffa Health Pty Ltd - Specimen receptacle IVDs
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Intended Purpose

A covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
August 31, 2021
Effective Date
August 31, 2021
Manufacturer
Country
China
Address
Southern End of Quancheng Road Chengwu County, Heze City, Shandong Province, 274200