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Roche Diagnostics cobasยฎ pro i 601 analyzer - HSA Registration DE0510492

Access comprehensive regulatory information for Roche Diagnostics cobasยฎ 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.

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CLASS C IVD
DE0510492
Roche Diagnostics cobasยฎ pro i 601 analyzer
HSA Registration Number: DE0510492
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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.

Device 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 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