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Singapore HSA registration DE0510657

Roffe International BUZUD Influenza A/B Antigen Rapid Test for Self-testing

Singapore flagSingapore·CLASS B IVD·Roffe International Holdings Pte Ltd·Registered April 30, 2025
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0510657
Registration Date
April 30, 2025
Retention Due Date
April 29, 2026
Product description
The Influenza A & B Ag Rapid Test Cassette (Swab) is an in vitro chromatographic immunoassay designed for the qualitative and differential detection of Influenza A (including subtype H1N1) and Influenza B nucleoprotein antigens. It is intended for use with nasal swab specimens from individuals exhibiting symptoms such as sudden onset of fever, dry cough, headache, and muscle or joint pain. This test serves as an aid in the rapid diagnosis of Influenza A and B viral infections. It is strictly for in vitro diagnostic use and is intended for self-testing.
Product Owner
Name
Roffe International Holdings Pte Ltd
Short Name
Roffe International Holdings Pte Ltd
Address
585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Registrant
Name
Roffe International Holdings Pte Ltd
Address
585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Importer
Name
ROFFE INTERNATIONAL HOLDINGS PTE LTD
Address
585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Model information
Model Name(s)
Influenza A/B Antigen Rapid Test
Model Identifier(s)
303051
About this record

Access comprehensive regulatory information for Roffe International BUZUD Influenza A/B Antigen Rapid Test for Self-testing 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 DE0510657 and owned by Roffe International Holdings Pte Ltd. The device was registered on April 30, 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