Singapore HSA registration DE0509979
Bioptik EasyTouch® GCHb System and Haemoglobin Test Strips
Singapore·CLASS B IVD·Bioptik Technology, Inc.·Registered October 25, 2024Device 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 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.
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
About this record
Access comprehensive regulatory information for Bioptik EasyTouch® 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD