Singapore HSA registration DE0508872
Boditech AFIAS-6
Singapore·CLASS C IVD·Boditech Med Inc.·Registered January 22, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0508872
- Registration Date
- January 22, 2024
- Retention Due Date
- January 21, 2026
Product description
AFIAS-6 is an analyzer intended for use in conjunction with fluorescence immunoassay (FIA) kits for quantitative, semi- quantitative and qualitative measurements of various analytes. For in vitro diagnostic use only
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-6
- Model Identifier(s)
- FPRR020
About this record
Access comprehensive regulatory information for Boditech AFIAS-6 in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0508872 and owned by Boditech Med Inc.. The device was registered on January 22, 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 C IVD