Singapore HSA registration DE0510378
Roffe International BUZUD Safe AQ UG Uric Acid Test Strip
Singapore·CLASS B IVD·Roffe International Holdings Pte Ltd·Registered February 21, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0510378
- Registration Date
- February 21, 2025
- Retention Due Date
- February 20, 2026
Product description
The Safe AQ UG uric acid test strip is used only with Safe AQ UG Blood Glucose and Uric Acid Meter to quantitative determine uric acid in human capillary whole blood samples or in the venous samples. It is intended for use outside the body only (in vitro diagnostic use) for self testing or professional use as an aid in the management of hypeuricemia (HUA). Not for screening or diagnosis of hypeuricemia (HUA).
Product Owner
- Short Name
- Roffe International Holdings Pte Ltd
- Address
- 585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Registrant
- Address
- 585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Importer
- Address
- 585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Model information
- Model Name(s)
- BUZUD Safe AQ UG Blood Glucose and Uric Acid Meter BUZUD Safe AQ UG Uric Acid Test Strip BUZUD Uric Acid Control Solution BUZUD Uric Acid Control Solution
- Model Identifier(s)
- BUZUD Safe AQ UG Blood Glucose and Uric Acid Meter BUZUD Safe AQ UG Uric Acid Test Strip BUZUD Uric Acid Control Solution level 1 BUZUD Uric Acid Control Solution level 2
About this record
Access comprehensive regulatory information for Roffe International BUZUD Safe AQ UG Uric Acid Test Strip 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 DE0510378 and owned by Roffe International Holdings Pte Ltd. The device was registered on February 21, 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