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HSA · registration DE0510321

Roffe International BUZUD Glucose Test Strips

SingaporeGeneral HospitalClass CRoffe International Holdings Pte Ltd
Official record identity
Registration number
DE0510321
Model name
BUZUD Glucose Test Strips; BUZUD Glucose Control Solution; BUZUD Glucose, Ketone and Uric acid meter; BUZUD Glucose, Ketone and Uric acid meter
Model identifier
1026; A-1; MGM-1; MGM-2
Registration date
February 07, 2025
Classification
Risk class
Class C
Official value: CLASS C
Published category
General Hospital
Published parties
Registrant / registration holder
ROFFE INTERNATIONAL HOLDINGS PTE. LTD.
Official description

The BUZUD Blood Glucose Test Strips are thin strips with a chemical reagent system. They work to measure the glucose concentration with the BUZUD Glucose, Ketone and Uric Acid meter. For in vitro diagnostic use. Test strips are to be used only outside the body for testing purposes. When used for self-testing (over-the-counter testing), the system can accept fresh human capillary whole blood obtained from the fingertip, forearm, and/or palm by non- professional users. Test results serve only as helpful information, not as proof for a clinical diagnosis.

Additional source fields
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
About this record

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.