Singapore HSA registration DE0509317
Boditech AFIAS CRP
Singapore·CLASS B IVD·Boditech Med Inc.·Registered May 27, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509317
- Registration Date
- May 27, 2024
- Retention Due Date
- May 26, 2025
Product description
AFIAS CRP is a fluorescence immunoassay (FIA) for the quantitative determination of CRP (C-reactive protein) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of autoimmune diseases and infectious processes, such as rheumatoid arthritis. 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)
- Boditech CRP Control Boditech CRP Calibrator AFIAS CRP
- Model Identifier(s)
- CFPO-100 CFPO-112 SMFP-2
About this record
Access comprehensive regulatory information for Boditech AFIAS CRP 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 DE0509317 and owned by Boditech Med Inc.. The device was registered on May 27, 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