HSA · registration DE0510277Roffe International BUZUD Blood Lipid Test Strip
- Registration number
- DE0510277
- Model name
- Blood Lipid Test Strip; Blood Lipid Analyzer; Blood Lipid Analyzer
- Model identifier
- PFS 30; PFS-30; PFS-30A
- Registration date
- January 22, 2025
- Risk class
- Class B
- Product owner
- Roffe International Holdings Pte Ltd
- Registrant / registration holder
- ROFFE INTERNATIONAL HOLDINGS PTE. LTD.
Blood Lipid Test strip is used to quantitative detection of total cholesterol (TC), high-density lipoprotein cholesterol (HDL) and triglyceride (TG) level in human whole blood samples (venous or capillary blood samples). The test strip is intended to be used by lay persons and health care professional. It is suitable for the daily blood lipid detection of people with abnormal or normal blood lipid, but not suitable for neonatal testing. Test result for the product should not be used for diagnosis of cardiac vascular diseases.
- 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.