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Roffe International BUZUD Safe AQ UG Uric Acid Test Strip - HSA Registration DE0510378

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.

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CLASS B IVD
DE0510378
Roffe International BUZUD Safe AQ UG Uric Acid Test Strip
HSA Registration Number: DE0510378
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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).

Device 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 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