Roffe International BUZUD Glucose Test Strips
- 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
- Risk class
- Class C
- Product owner
- Roffe International Holdings Pte Ltd
- Registrant / registration holder
- ROFFE INTERNATIONAL HOLDINGS PTE. LTD.
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.
- 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.