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Boditech AFIAS-6 - HSA Registration DE0508872

Access comprehensive regulatory information for Boditech AFIAS-6 in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0508872 and owned by Boditech Med Inc.. The device was registered on January 22, 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 C IVD
DE0508872
Boditech AFIAS-6
HSA Registration Number: DE0508872
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Product Description

AFIAS-6 is an analyzer intended for use in conjunction with fluorescence immunoassay (FIA) kits for quantitative, semi- quantitative and qualitative measurements of various analytes. For in vitro diagnostic use only

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0508872
Registration Date
January 22, 2024
Retention Due Date
January 21, 2026
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)
AFIAS-6
Model Identifier(s)
FPRR020