HSA · registration DE0509839

Boditech AFIAS HbA1c Neo

Name: Boditech AFIAS HbA1c Neo — HSA DE0509839
Creator: Boditech Med Inc.
Keywords: Boditech AFIAS HbA1c Neo, Boditech AFIAS HbA1c Neo, DE0509839, Clinical chemistry, HSA

SingaporeClinical chemistryClass BBoditech Med Inc.

Verified

Official record identity

Registration number: DE0509839
Model name: Boditech HbA1c Calibrator; Boditech HbA1c Control; AFIAS HbA1c Neo
Model identifier: CFPO-108; CFPO-96; SMFP-109
Registration date: September 25, 2024

Classification

Risk class: Class B
Published category: Clinical chemistry

Published parties

Product owner: Boditech Med Inc.
Registrant / registration holder: ALL EIGHTS (SINGAPORE) PRIVATE LIMITED

Official 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.

Additional source fields

Product owner address: 43 Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do, 23498, Korea, South
Registrant address: 6 HARPER ROAD, #03-02, LEONG HUAT BUILDING, Singapore 369674

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.