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Roche Diagnostics GmbH

Manufacturer • Germany · 207 devices on the TGA ARTG · 4 device classes · Aug 17, 2010 – Feb 22, 2024

207
Total Devices
4
Device Classes
2010
Earliest
2024
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
Elecsys HCV Duo (cobas e 402/801) - Hepatitis C virus antibody/antigen IVD, kit, chemiluminescent immunoassay
ARTG 442030
Class IIIFeb 22, 2024
Sponsor: Roche Diagnostics Australia Pty Limited
Elecsys HCV Duo (cobas e 402/801) - Hepatitis C virus antibody/antigen IVD, kit, chemiluminescent immunoassay
Class IIIFeb 22, 2024
Sponsor: Roche Diagnostics Australia Pty Limited
Hepatitis E virus IVDs
ARTG 441110
Class IIbFeb 15, 2024
Sponsor: Roche Diagnostics Australia Pty Limited
Hepatitis E virus IVDs
Class IIbFeb 15, 2024
Sponsor: Roche Diagnostics Australia Pty Limited
Elecsys HBeAg quant (cobas e 411/601/602) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Class IIIFeb 13, 2024
Sponsor: Roche Diagnostics Australia Pty Limited
Elecsys HBeAg quant (cobas e 402/801) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
ARTG 440850
Class IIIFeb 13, 2024
Sponsor: Roche Diagnostics Australia Pty Limited
Elecsys HBeAg quant (cobas e 402/801) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Class IIIFeb 13, 2024
Sponsor: Roche Diagnostics Australia Pty Limited
PreciControl HBeAg quant - Hepatitis B virus e-antigen IVD, control
ARTG 440890
Class IIIFeb 13, 2024
Sponsor: Roche Diagnostics Australia Pty Limited
Elecsys HBeAg quant (cobas e 411/601/602) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
ARTG 440910
Class IIIFeb 13, 2024
Sponsor: Roche Diagnostics Australia Pty Limited
PreciControl HBeAg quant - Hepatitis B virus e-antigen IVD, control
Class IIIFeb 13, 2024
Sponsor: Roche Diagnostics Australia Pty Limited
View All 207 Devices →
Risk class distribution
Devices by risk class
Class I
13
6.3% of total
Class IIa
52
25.1% of total
Class IIb
61
29.5% of total
Class III
81
39.1% of total
About this profile

Explore comprehensive manufacturer profile for Roche Diagnostics GmbH through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 207 medical devices registered with TGA ARTG across 4 device classes. This manufacturer is based in Germany. Their registration history spans from Aug 17, 2010 to Feb 22, 2024.

This page provides detailed insights including recent device registrations, risk class distribution (Class I: 13, Class IIa: 52, Class IIb: 61, Class III: 81), 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 AI207 Devices4 Device Classes