Roche Diagnostics GmbH - Manufacturer 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 IIb: 61, Class III: 81, Class IIa: 52, Class I: 13), 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.

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207 Devices

4 Device Classes

Roche Diagnostics GmbH

Manufacturer • Germany

207

Total Devices

4

Device Classes

2010

Earliest

2024

Latest

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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

Sponsor: Roche Diagnostics Australia Pty Limited

Elecsys HCV Duo (cobas e 402/801) - Hepatitis C virus antibody/antigen IVD, kit, chemiluminescent immunoassay

Sponsor: Roche Diagnostics Australia Pty Limited

Hepatitis E virus IVDs

Sponsor: Roche Diagnostics Australia Pty Limited

Hepatitis E virus IVDs

ARTG 441110

Sponsor: Roche Diagnostics Australia Pty Limited

PreciControl HBeAg quant - Hepatitis B virus e-antigen IVD, control

Sponsor: Roche Diagnostics Australia Pty Limited

PreciControl HBeAg quant - Hepatitis B virus e-antigen IVD, control

ARTG 440890

Sponsor: Roche Diagnostics Australia Pty Limited

Elecsys HBeAg quant (cobas e 411/601/602) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

Sponsor: Roche Diagnostics Australia Pty Limited

Elecsys HBeAg quant (cobas e 402/801) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

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

Sponsor: Roche Diagnostics Australia Pty Limited

Elecsys HBeAg quant (cobas e 402/801) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

ARTG 440850

Sponsor: Roche Diagnostics Australia Pty Limited

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