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Roffe International BUZUD Blood Lipid Test Strip - HSA Registration DE0510277

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.

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CLASS B IVD
DE0510277
Roffe International BUZUD Blood Lipid Test Strip
HSA Registration Number: DE0510277
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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.

Device 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 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