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Singapore HSA registration DE0510617

Roche Diagnostics cobas® Ionify Vitamin D 25 and 24,25

Singapore flagSingapore·CLASS B IVD·Roche Diagnostics GmbH·Registered April 22, 2025
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0510617
Registration Date
April 22, 2025
Retention Due Date
April 21, 2026
Product description
Liquid Chromatography Tandem Mass Spectrometry reagent carrier for the in vitro determination of total 24,25‑dihydroxyvitamin D and total 25‑hydroxyvitamin D in human serum and plasma. The determination of total 24,25‑dihydroxyvitamin D is used as an aid in diagnosis and monitoring of Vitamin D related disorders. The determination of total 25‑hydroxyvitamin D is used for the assessment of Vitamin D sufficiency.
Product Owner
Name
Roche Diagnostics GmbH
Short Name
Roche Diagnostics GmbH
Address
Sandhofer Strasse 116, 68305 Mannheim, GERMANY
Registrant
Name
Roche Diagnostics Asia Pacific Pte Ltd
Address
8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Importer
Name
Roche Diagnostics Asia Pacific Pte Ltd
Address
8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Model information
Model Name(s)
Ionify Vitamin D 25 and 24,25 Ionify CalSet Steroids and Vitamin D Ionify ControlSet Steroids and Vitamin D
Model Identifier(s)
9634622190 9637273190 9646965190
About this record

Access comprehensive regulatory information for Roche Diagnostics cobas® Ionify Vitamin D 25 and 24,25 in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510617 and owned by Roche Diagnostics GmbH. The device was registered on April 22, 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 B IVD