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Bioptik EasyTouch® Blood Glucose - HSA Registration DE0510610

Access comprehensive regulatory information for Bioptik EasyTouch® Blood Glucose 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 DE0510610 and owned by Bioptik Technology, Inc.. The device was registered on April 21, 2025.

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
DE0510610
Bioptik EasyTouch® Blood Glucose
HSA Registration Number: DE0510610
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Product Description

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

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0510610
Registration Date
April 21, 2025
Retention Due Date
April 20, 2026
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 Blood Glucose / Cholesterol / Hemoglobin Multi-Function Monitoring System Lancing Device EasyTouch Glucose Test Strips EasyTouch Glucose Test Strips EasyTouch Glucose Test Strips Sterilance Lancet 30G
Model Identifier(s)
ET-321 LD-E1 SG119-10 SG119-25 SG119-50 Soft