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Boditech hemochroma PLUS - HSA Registration DE0509063

Access comprehensive regulatory information for Boditech hemochroma PLUS 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 DE0509063 and owned by Boditech Med Inc.. The device was registered on March 15, 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
DE0509063
Boditech hemochroma PLUS
HSA Registration Number: DE0509063
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Product Description

hemochroma PLUS is a portable analyzer intended for use in conjuction with Microcuvettes for quantitative measurement of total hemoglobin in human blood. For in vitro diagnostic use only.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0509063
Registration Date
March 15, 2024
Retention Due Date
March 14, 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)
Microcuvettes hemochroma PLUS Control hemochroma PLUS Calibrator hemochroma PLUS
Model Identifier(s)
CFPO-27 CFPO-30 CFPO-35 FPRR016