Pure Global

General laboratoryware IVDs - ARTG 475206

Access comprehensive regulatory information for General laboratoryware IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 475206 and sponsored by Abacus dx Pty Ltd, manufactured by SD Biosensor Inc in South Korea. The device registration started on January 08, 2025.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 475206
Class I
General laboratoryware IVDs
ARTG ID: 475206
Good Name: Abacus dx Pty Ltd - General laboratoryware IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The SD Biosensor calibration kits are designed to check the functionality of the optical systems in the STANDARD M10, STANDARD F200 Analyzer, and STANDARD F2400 Analyzer.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
475206
Start Date
January 08, 2025
Effective Date
January 08, 2025
Manufacturer
Country
South Korea
Address
C-4th & 5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690