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Singapore HSA registration DE0014303

Nova Biomedical Nova StatSensor-I Creatinine Hospital Meter System

Singapore flagSingapore·CLASS C IVD·Nova Biomedical·Registered November 14, 2013
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
HSA Product Code
HSAMDC00106
HS Code
38220090
Registration information
Registration Number
DE0014303
Registration Date
November 14, 2013
Change Notification Approval Date
August 21, 2014
Retention Due Date
November 13, 2025
Product description
The StatSensor-I Creatinine Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. This IVD System is not intended for use in neonates.
Product Owner
Name
Nova Biomedical
Short Name
Nova Biomedical
Address
Nova Biomedical Headquarters, 200 Prospect Street,, Waltham, 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)
Nova StatSensor Creatinine Linearity Kit, 5 levels Nova StatSensor Creatinine Docking Station Nova StatSensor-i Creatinine Test Strips Nova StatSensor Creatinine Control Solution ( level 1) Nova StatSensor Creatinine Control Solution ( level 2) Nova StatSensor Creatinine Control Solution ( level 3) Nova StatSensor-i Creatinine Hospital Meter Kit
Model Identifier(s)
42173 42225 43272 43921 43922 43923 45328
About this record

Access comprehensive regulatory information for Nova Biomedical Nova StatSensor-I Creatinine 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 DE0014303 and owned by Nova Biomedical. The device was registered on November 14, 2013.

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