Singapore HSA registration DE0510277
Roffe International BUZUD Blood Lipid Test Strip
Singapore·CLASS B IVD·Roffe International Holdings Pte Ltd·Registered January 22, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0510277
- Registration Date
- January 22, 2025
- Retention Due Date
- January 21, 2026
Product description
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
- 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)
- Blood Lipid Test Strip Blood Lipid Analyzer Blood Lipid Analyzer
- Model Identifier(s)
- PFS 30 PFS-30 PFS-30A
About this record
Access comprehensive regulatory information for Roffe International BUZUD Blood Lipid 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 DE0510277 and owned by Roffe International Holdings Pte Ltd. The device was registered on January 22, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD