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Boditech AFIAS CRP - HSA Registration DE0509317

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.

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CLASS B IVD
DE0509317
Boditech AFIAS CRP
HSA Registration Number: DE0509317
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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.

Device 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 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