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Boditech AFIAS HbA1c Neo - HSA Registration DE0509839

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.

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CLASS B IVD
DE0509839
Boditech AFIAS HbA1c Neo
HSA Registration Number: DE0509839
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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.

Device 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 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