Singapore HSA registration DE0510492
Roche Diagnostics cobas® pro i 601 analyzer
Singapore·CLASS C IVD·Roche Diagnostics GmbH·Registered March 24, 2025Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510492
- Registration Date
- March 24, 2025
- Change Notification Approval Date
- April 22, 2025
- Retention Due Date
- March 23, 2026
Product description
The cobas pro i 601 analyzer is an integrated fully automated, random-access, software controlled clinical analyzer for bead-based, liquid chromatography, sample preparation and mass spectrometry analysis for quantitative in-vitro determinations. The cobas i601 analyzer is intended to identify naturally occurring and synthetic compounds (e.g., steroids, vitamins, opiates, benzodiazepines and others) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratio.
Product Owner
- Short Name
- Roche Diagnostics GmbH
- Address
- Sandhofer Strasse 116, 68305 Mannheim, GERMANY
Registrant
- Address
- 8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Importer
- Address
- 8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Model information
- Model Name(s)
- cobas pro sample supply unit cobas pro sample buffer unit HPLC Cartridge Rapid Cartridge B cobas i601 analytical unit
- Model Identifier(s)
- 9205632001 9205675001 9511725190 9511741190 10271582001
About this record
Access comprehensive regulatory information for Roche Diagnostics cobas® pro i 601 analyzer in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510492 and owned by Roche Diagnostics GmbH. The device was registered on March 24, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD