Australia TGA ARTG record

General laboratoryware IVDs

Australia TGA ARTG Registered Device · IVF Gen (Australia) · Jiangsu KangJian Medical Apparatus Co Ltd · Class I · Started June 14, 2023

Good Name: IVF Gen (Australia) - General laboratoryware IVDs

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: June 14, 2023
Effective Date: June 14, 2023

Sponsor

Name: IVF Gen (Australia)

Manufacturer

Name: Jiangsu KangJian Medical Apparatus Co Ltd
Country: China
Address: No 16 Zhanqian Road, Jiangyan, Taizhou, 225500

Intended purpose

Lab consumables/disposable products used for testing, analysis and evaluation of human gametes (sperms & oocytes) and human embryos in IVF laboratory. Individual products are as below: (1) Centrifuge Tubes (2) Culture Tubes (3) Petri Dishes (4) Serological Pipettes (5) Transfer Pipettes (6) Cryo Vials

About this record

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 sponsored by IVF Gen (Australia), manufactured by Jiangsu KangJian Medical Apparatus Co Ltd in China. The device registration started on June 14, 2023.

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.