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Singapore HSA registration DE0509715

SD Biosensor STANDARD™ Mentor Blood Glucose Test Strip

Singapore flagSingapore·CLASS C IVD·SD Biosensor, Inc.·Registered September 02, 2024
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0509715
Registration Date
September 02, 2024
Retention Due Date
September 01, 2025
Product description
STANDARD™ Mentor blood glucose test strip is designed for self testing blood glucose using fresh capillary whole blood from fingertip, palm, forearm or upper arm. This strip is intended to use outside the body (in vitro diagnostic use) in home. The STANDARD Mentor blood glucose meter must be used with only STANDARD Mentor blood glucose test strip. This system is indicated for home (over-the-counter or OTC) by person with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of diabetes or for testing newborns.
Product Owner
Name
SD Biosensor, Inc.
Short Name
SD Biosensor, Inc.
Address
C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, KOREA, REPUBLIC OF
Registrant
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
Model Name(s)
GlucoNaviiApp STANDARD™ DMS (Diabetes Management Software) STANDARD™ Mentor Blood Glucose Monitoring System STANDARD™ Mentor BT Blood Glucose Monitoring System STANDARD™ Glucose Check Strip-B STANDARD™ Glucose Control Solution Lancet Lancing device STANDARD™ Mentor Blood Glucose Test Strip
Model Identifier(s)
01APP10 01DMS10 01GC210 01GC270 01GCH11 01GCS10 01GL18 01GLD13 01GS21
About this record

Access comprehensive regulatory information for SD Biosensor STANDARD™ Mentor Blood Glucose Test Strip 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 DE0509715 and owned by SD Biosensor, Inc.. The device was registered on September 02, 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 C IVD