Singapore HSA registration DE0509839
Boditech AFIAS HbA1c Neo
Singapore·CLASS B IVD·Boditech Med Inc.·Registered September 25, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509839
- Registration Date
- September 25, 2024
- Retention Due Date
- September 24, 2025
Product description
AFIAS HbA1c Neo is a fluorescence immunoassay (FIA) for the quantitative determination of HbA1c (Hemoglobin A1c) in human whole blood. It is useful as an aid in management and monitoring of the long-term glycemic status in patients with diabetes mellitus.
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 HbA1c Calibrator Boditech HbA1c Control AFIAS HbA1c Neo
- Model Identifier(s)
- CFPO-108 CFPO-96 SMFP-109
About this record
Access comprehensive regulatory information for Boditech AFIAS HbA1c Neo 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 DE0509839 and owned by Boditech Med Inc.. The device was registered on September 25, 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