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Bioptik EasyTouchยฎ GCHb System and Haemoglobin Test Strips - HSA Registration DE0509979

Access comprehensive regulatory information for Bioptik EasyTouchยฎ GCHb System and Haemoglobin Test Strips 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 DE0509979 and owned by Bioptik Technology, Inc.. The device was registered on October 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
DE0509979
Bioptik EasyTouchยฎ GCHb System and Haemoglobin Test Strips
HSA Registration Number: DE0509979
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Product Description

EasyTouch Blood Hemoglobin Test Strips are designed for in vitro diagnostic use with the EasyTouch Blood Hemoglobin Meter for self-testing the quantitative measure of hemoglobin level in fresh capillary whole blood. This system is suitable for hemoglobin management at home or professional use.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical toxicology
Registration Information
Registration Number
DE0509979
Registration Date
October 25, 2024
Retention Due Date
October 24, 2025
Product Owner
Short Name
Bioptik Technology, Inc.
Address
No. 188, Jhonghua South Road,, Gongguan Village, Jhunan Township, Miaoli County, 35057, TAIWAN
Registrant
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model Information
Model Name(s)
EasyTouch GCHb Meter ET-321 EasyTouch Hemoglobin Test Strips EasyTouch Hemoglobin Test Strips
Model Identifier(s)
ET-321 SH102-05 SH102-25