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Singapore HSA registration DE0506901

Nova StatStrip Glucose and ß-Ketone Hospital Meter System

Singapore flagSingapore·CLASS C IVD·Nova Biomedical·Registered May 31, 2022
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0506901
Registration Date
May 31, 2022
Retention Due Date
May 30, 2025
Product description
The Nova StatStrip Glucose and ß-Ketone Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonate heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy. It is also intended for the quantitative determination of β-Ketone in capillary finger stick and venous whole blood throughout all hospital and all professional healthcare settings. The system should only be used with single-use, autodisabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia and ketonemia.
Product Owner
Name
Nova Biomedical
Short Name
Nova Biomedical
Address
Nova Biomedical Headquarters, 200 Prospect Street,, MA 02454-9141, UNITED STATES
Registrant
Name
Bio Laboratories Pte Ltd
Address
10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Importer
Name
BIO LABORATORIES PTE LTD
Address
10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Model information
Model Name(s)
StatStrip StatStrip Xpress GLU - Test Strips StatStrip StatStrip Xpress Glu Ket Control, Level 1 StatStrip StatStrip Xpress Glu Ket Control, Level 2 StatStrip StatStrip Xpress Glu Ket Control, Level 3 StatStrip StatStrip Xpress Glu Ket Linearity, Level 1, Level 2, Level 3, Level 4, Level 5 StatStrip StatStrip Xpress KET - Test Strips StatStrip GLU KET Meter with Battery and Quick Reference Guide
Model Identifier(s)
42214 46947 46948 46949 46950 46951 53755
About this record

Access comprehensive regulatory information for Nova StatStrip Glucose and ß-Ketone Hospital Meter 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 DE0506901 and owned by Nova Biomedical. The device was registered on May 31, 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