Singapore HSA registration DE0008107
Nova StatStrip Glucose Monitoring System
Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
- HSA Product Code
- HSAMDC00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0008107
- Registration Date
- December 02, 2011
- Change Notification Approval Date
- August 21, 2014
- Retention Due Date
- December 01, 2025
Product description
The Nova StatStrip Xpress Glucose Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of Glucose (Glu) in capillary, venous, arterial, and neonatal whole blood. The Nova StatStrip Glucose Test Strips are intended for use only with StatStrip Glucose Meter for quantitative tests. The Glucose Meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is plasma calibrated to allow easy comparison of results with laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use). Nove StatStrip Glucose Control Solution Used as a quality control check to ensure that the StatStrip Glucose Meter and the Glucose Meter Test Strips are working properly as a system. Nova StatStrip Glucose Linearity Kit The Linearity solutions are used to check the linearity of the StatStrip Glucose Meter System.
Product Owner
- Name
- Nova Biomedical
- Short Name
- Nova Biomedical
- Address
- Nova Biomedical Headquarters, 200 Prospect Street,, Waltham, MA 02454-9141, UNITED STATES
Registrant
- Address
- 10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Importer
- Address
- 10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Model information
- Model Name(s)
- Nova Statstrip Glucose Controls solution ( level 1, 2, 3) Nova Statstrip Glucose Linearity kit, 5 levels StartStrip Glucose test strip Nova Statstrip Glucose Hospital meter StatStrip Docking Station with AC adaptor Nova Statstrip Xpress Glucose Hospital Meter ( mg/dl) Nova Statstrip Xpress Glucose Hospital Meter ( mmmol/L)
- Model Identifier(s)
- 41741, 41742, 41743 42173 42214 42224 42225 43404 44321
About this record
Access comprehensive regulatory information for Nova StatStrip 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 DE0008107 and owned by Nova Biomedical. The device was registered on December 02, 2011.
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