Australia TGA ARTG recordClinical chemistry biological screening IVDs
Australia TGA ARTG Registered Device · Profile Medical Devices Pty Ltd · MotilityCount ApS · Class IIa · Started December 15, 2022
Good Name: Profile Medical Devices Pty Ltd - Clinical chemistry biological screening IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- December 15, 2022
- Effective Date
- December 15, 2022
- Country
- Denmark
- Address
- Gl Koge Landevej 57 2, Valby, DK, 2500
The SwimCount™ Sperm Quality Test is a qualitative test that detects sperm concentration above or below 5,000,000 Progressive Motile Sperm Cells per mL (PMSCs/mL). The test is intended for use as an aid in the determination of a man’s fertility status. For self-test use. The test kit includes the following components: • SwimCount™ Device • Semen Collection Cup • Syringe • Instructions for use
Access comprehensive regulatory information for Clinical chemistry biological screening IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Profile Medical Devices Pty Ltd, manufactured by MotilityCount ApS in Denmark. The device registration started on December 15, 2022.
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.