Registrant profile

Roche Diagnostics Asia Pacific Pte Ltd

Singapore·471 devices registered

Profile overview

Total Devices: 471
Device Classes: 5
Earliest: 2004
Latest: 2025

Recent registrations

Latest 10 HSA device registrations

Ventana VENTANA CLDN18 (43-14A) RxDx AssayMay 02, 2025

Registration: DE0510669

Class: CLASS C IVD

Roche Diagnostics cobas® Ionify Vitamin D 25 and 24,25Apr 22, 2025

Registration: DE0510617

Class: CLASS B IVD

Roche Diagnostics cobas® Tina-quant Cardiac high sensitivity CRP IIIApr 10, 2025

Registration: DE0510574

Class: CLASS C IVD

Roche Diagnostics Elecsys Anti-HBs IIIApr 04, 2025

Registration: DE0510553

Class: CLASS D IVD

Ventana VENTANA FOLR1 (FOLR1-2.1) RxDx AssayApr 03, 2025

Registration: DE0510544

Class: CLASS C IVD

Roche Diagnostics cobas® pro i 601 analyzerMar 24, 2025

Registration: DE0510492

Class: CLASS C IVD

Roche Diagnostics uPath HER2 Dual ISH image analysis for Breast AlgorithmFeb 25, 2025

Registration: DE0510389

Class: CLASS C IVD

Ventana VENTANA PD-L1 (SP142) AssayJan 10, 2025

Registration: DE0510229

Class: CLASS C IVD

Cell Marque Lysozyme Rabbit Polyclonal AntibodyDec 26, 2024

Registration: DE0510182

Class: CLASS B IVD

Roche Diagnostics Elecsys® Anti-HEV IgGDec 19, 2024

Registration: DE0510168

Class: CLASS C IVD

Device class distribution

Devices by class

CLASS B: 1 (0.2%)
CLASS B IVD: 284 (60.3%)
CLASS C: 1 (0.2%)
CLASS C IVD: 150 (31.8%)
CLASS D IVD: 35 (7.4%)

About this profile

Explore comprehensive registrant profile for Roche Diagnostics Asia Pacific Pte Ltd through Pure Global AI's free Singapore medical device database. This company has registered 471 medical devices with HSA across 5 device classes. Their registration history spans from Oct 27, 2004 to May 02, 2025.

This page provides detailed insights including recent registrations, device class distribution (CLASS D IVD: 35, CLASS C IVD: 150, CLASS C: 1, CLASS B IVD: 284, CLASS B: 1), and complete regulatory information from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry.

Free Registrant ProfilePowered by Pure Global AI471 Devices5 Device Classes