SD Biosensor STANDARD™ Mentor Blood Glucose Test Strip - HSA Registration DE0509715
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.
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.