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Devyser AB

Manufacturer • Sweden · 4 devices on the TGA ARTG · 2 device classes · Jun 04, 2024 – Feb 28, 2025

4
Total Devices
2
Device Classes
2024
Earliest
2025
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
Devyser RHD 8-R060-78 8-R060-390 - Foetal blood group genotyping IVD, kit, nucleic acid technique (NAT)
ARTG 481205
Class IIIFeb 28, 2025
Sponsor: Abacus dx Pty Ltd
Human genetics-related IVDs
ARTG 461285
Class IIbAug 29, 2024
Sponsor: Thermo Fisher Scientific Australia Pty Ltd
Constitutional chromosomal disorder IVDs
ARTG 450786
Class IIbJun 04, 2024
Sponsor: Abacus dx Pty Ltd
Constitutional chromosomal disorder IVDs
Class IIbJun 04, 2024
Sponsor: Abacus dx Pty Ltd
Risk class distribution
Devices by risk class
Class IIb
3
75.0% of total
Class III
1
25.0% of total
About this profile

Explore comprehensive manufacturer profile for Devyser AB through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 4 medical devices registered with TGA ARTG across 2 device classes. This manufacturer is based in Sweden. Their registration history spans from Jun 04, 2024 to Feb 28, 2025.

This page provides detailed insights including recent device registrations, risk class distribution (Class IIb: 3, Class III: 1), and complete regulatory information 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.

Free Manufacturer ProfilePowered by Pure Global AI4 Devices2 Device Classes