Pure Global

Nova Stat Profile Prime CCS Analyzer - HSA Registration DE0504738

Access comprehensive regulatory information for Nova Stat Profile Prime CCS Analyzer 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 DE0504738 and owned by Nova Biomedical. The device was registered on July 23, 2020.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS C IVD
DE0504738
Nova Stat Profile Prime CCS Analyzer
HSA Registration Number: DE0504738
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Stat Profile Prime CCS Analyzer and Stat Profile Prime CCS Comp Analyzers are intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for the quantitative determination of pH, PCO2, PO2, Hct, Na+, K+, Cl-, and iCa in heparinized whole blood. The Stat Profile Prime CCS Comp Analyzer is also intended for determination of Glu (Glucose), and Lac (Lactate) in heparinized whole blood.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0504738
Registration Date
July 23, 2020
Retention Due Date
July 22, 2025
Product Owner
Short Name
Nova Biomedical
Address
Nova Biomedical Headquarters, 200 Prospect Street,, 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)
Linearity Standard Set A Levels 1,2,3,4 Multipack Prime Sensor Card CCS Prime Sensor Card CCS Comp Prime Reference Cartridge Prime Auto QC Cartridge CCS 200 Sample Prime Calibrator Cartridge CCS Comp 300 Sample Prime Ampuled Control ABG/CCS Prime CCS Prime CCS Comp Prime Calibrator Cartridge CCS Comp 100 Sample Prime Calibrator Cartridge CCS 100 Sample Prime Sensor Card CCSPrime Calibrator Cartridge CCS 300 Sample Prime Auto QC Cartridge CCS 300 Sample Prime Calibrator Cartridge CCS Comp 400 Sample Prime Calibrator Cartridge CCS 200 Sample Prime Calibrator Cartridge CCS Comp 200 Sample Prime Auto QC Cartridge CCS 100 Sample Prime Calibrator Cartridge CCS 400 Sample Prime Calibrator Cartridge CCS 500 Sample Prime Calibrator Cartridge CCS Comp 500 Sample Prime CCS w/Scanner Prime CCS Comp w/Scanner Nova Linearity Level 1,2,3,4 Prime Sensor Card CCS (High Volume) Prime Sensor Card CCS Comp (High Volume)
Model Identifier(s)
25217 42032 42033 42043 45150 52427 52714 52856 52857 52861 52862 52863 52864 53105 53364 53365 53455 53466 53467 53469 53656 53657 55229 55263 55264