HSA · registration DE0510378Roffe International BUZUD Safe AQ UG Uric Acid Test Strip
- Registration number
- DE0510378
- Model name
- 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
- 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
- Registration date
- February 21, 2025
- Risk class
- Class B
- Product owner
- Roffe International Holdings Pte Ltd
- Registrant / registration holder
- ROFFE INTERNATIONAL HOLDINGS PTE. LTD.
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 address
- 585 NORTH BRIDGE ROAD, #01-02, RAFFLES HOSPITAL, Singapore 188770
- Registrant address
- 585 NORTH BRIDGE ROAD, #01-02, RAFFLES HOSPITAL, Singapore 188770
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.