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HSA · registration DE0510610

Bioptik EasyTouch® Blood Glucose

SingaporeClinical chemistryClass CBioptik Technology, Inc.
Verified
Official record identity
Registration number
DE0510610
Model name
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
ET-321; LD-E1; SG119-10; SG119-25; SG119-50; Soft
Registration date
April 21, 2025
Classification
Risk class
Class C
Official value: CLASS C
Published category
Clinical chemistry
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Published parties
Product owner
Bioptik Technology, Inc.
Registrant / registration holder
BIOMED DIAGNOSTICS PTE LTD
Official 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.

Additional source fields
Product owner address
No. 188, Jhonghua South Road,, Gongguan Village, Jhunan Township, Miaoli County, 35057, Taiwan
Registrant address
18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.