Singapore HSA registration DE0509164
Boditech AFIAS Flu A+B
Singapore·CLASS B IVD·Boditech Med Inc.·Registered April 12, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0509164
- Registration Date
- April 12, 2024
- Retention Due Date
- April 11, 2026
Product description
AFIAS Flu A+B is a fluorescence Immunoassay (FIA) for the qualitative determination on influenza infection to detect influenza A and influenza B viral antigen in nasopharyngeal swab specimens taken from symptomatic patients.
Product Owner
- Short Name
- Boditech Med Inc.
- Address
- 43 Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do, 23498, KOREA, REPUBLIC OF
Registrant
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Importer
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
- Model Name(s)
- AFIAS Flu A+B
- Model Identifier(s)
- SMFP-68
About this record
Access comprehensive regulatory information for Boditech AFIAS Flu A+B 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 DE0509164 and owned by Boditech Med Inc.. The device was registered on April 12, 2024.
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