HSA · registration DE0510492Roche Diagnostics cobas® pro i 601 analyzer
- Registration number
- DE0510492
- Model name
- cobas pro sample supply unit; cobas pro sample buffer unit; HPLC Cartridge; Rapid Cartridge B; cobas i601 analytical unit
- Model identifier
- 09205632001; 09205675001; 09511725190; 09511741190; 10271582001
- Registration date
- March 24, 2025
- Source update date
- March 11, 2026
- Risk class
- Class C
- Product owner
- Roche Diagnostics GmbH
- Registrant / registration holder
- ROCHE DIAGNOSTICS ASIA PACIFIC PTE LTD
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 address
- Sandhofer Strasse 116, 68305 Mannheim, Germany
- Registrant address
- 8 Kallang Avenue, #10-01/09, Aperia, Singapore 339509
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.