Australia flagARTG 378070

Clinical chemistry trace element IVDs

ARTG ID: 378070 · Beckman Coulter Australia Pty Ltd · Sentinel CH SpA · Class IIa · Started November 16, 2021

Good Name: Beckman Coulter Australia Pty Ltd - Clinical chemistry trace element IVDs

Device classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
378070
Start Date
November 16, 2021
Effective Date
November 16, 2021
Sponsor
Manufacturer
Country
Italy
Address
Via Robert Koch 2, Milan, 20152
Intended purpose

IVDs that are intended to be used for the qualitative and/or quantitative determination of clinical chemistry trace elements in a clinical specimen.

About this record

Access comprehensive regulatory information for Clinical chemistry trace element IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 378070 and sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Sentinel CH SpA in Italy. The device registration started on November 16, 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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