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Singapore HSA registration DE0509978

Bioptik EasyTouch® GCHb System and Cholesterol Test Strips

Singapore flagSingapore·CLASS B IVD·Bioptik Technology, Inc.·Registered October 25, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical toxicology
Registration information
Registration Number
DE0509978
Registration Date
October 25, 2024
Retention Due Date
October 24, 2025
Product description
EasyTouch Blood Cholesterol Test Strips are designed for in vitro diagnostic use with the EasyTouch Blood Cholesterol Meter for self-testing the quantitative measure of cholesterol level in fresh capillary whole blood. This system is suitable for cholesterol management at home or professional use.
Product Owner
Name
Bioptik Technology, Inc.
Short Name
Bioptik Technology, Inc.
Address
No. 188, Jhonghua South Road,, Gongguan Village, Jhunan Township, Miaoli County, 35057, TAIWAN
Registrant
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
Model Name(s)
EasyTouch GCHb Meter ET-321 EasyTouch Cholesterol Test Strips (C9) EasyTouch Cholesterol Test Strips (C9) EasyTouch Cholesterol Test Strips (C9)
Model Identifier(s)
ET-321 SC142-02 SC142-10 SC142-25
About this record

Access comprehensive regulatory information for Bioptik EasyTouch® GCHb System and Cholesterol 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 DE0509978 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD