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Singapore HSA registration DE0506968

Acon Laboratories On Call Sure Blood Glucose Monitoring System

Singapore flagSingapore·CLASS C IVD·ACON Laboratories, Inc.·Registered June 17, 2022
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0506968
Registration Date
June 17, 2022
Change Notification Approval Date
February 03, 2025
Retention Due Date
June 16, 2025
Product description
The On Call Sure Blood Glucose Monitoring System may be used by people with diabetes at home and by healthcare professionals for the quantitative measurement of glucose in capillary whole blood from the finger, forearm, and palm. Only professionals may also test neonatal, arterial and venous blood samples.
Product Owner
Name
ACON Laboratories, Inc.
Short Name
ACON Laboratories, Inc.
Address
5850 Oberlin Drive, #340, San Diego, California 92121, UNITED STATES
Registrant
Name
AJJ HEALTHCARE MANAGEMENT PTE LTD
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #02-04, SINGAPORE 149555
Importer
Name
AJJ HEALTHCARE MANAGEMENT PTE LTD
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #02-04, SINGAPORE 149555
Model information
Model Name(s)
On Call Sure Blood Glucose Meter On Call Sure Sync Blood Glucose Meter On Call Lancets On Call Lancing Device On Call Sure Blood Glucose Test Strips /100 Strips On Call Sure Blood Glucose Test Strips On Call Sure Blood Glucose Test Strips /25 Strips On Call Sure Blood Glucose Test Strips /200 Strips On Call Diabetes Management APP
Model Identifier(s)
G115-12U G115-12W G124-10A G124-11A G135-10U (100 Strips) G135-10U (50 Strips) G135-11U (25 Strips) G35-10U (200 Strips) On Call Diabetes Management APP
About this record

Access comprehensive regulatory information for Acon Laboratories On Call Sure Blood Glucose Monitoring System 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 DE0506968 and owned by ACON Laboratories, Inc.. The device was registered on June 17, 2022.

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