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Singapore HSA registration DE0508738

GE Carescape Canvas Patient Monitors

Singapore flagSingapore·CLASS C·GE Healthcare Finland Oy·Registered December 08, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508738
Registration Date
December 08, 2023
Retention Due Date
December 07, 2025
Product description
Intended for multi-parameter patient monitoring of; •hemodynamic(including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis & measurement, invasive pressure, NIBP, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, CO(thermodilution & pulse contour), temp., mixed venous oxygen saturation, central venous oxygen saturation, SPI)•respiratory status (impedance respiration, airway gases (CO2, O2, N2O, & anesthetic agents), spirometry, gas exchange)•neurophysiological status (including electroencephalography, Entropy, BIS,&neuromuscular transmission). Detect&generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions, pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2.
Product Owner
Name
GE Healthcare Finland Oy
Short Name
GE Healthcare Finland Oy
Address
Kuortaneenkatu 2, FI-00510 Helsinki, FINLAND
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
Model Name(s)
Carescape Canvas 1000 Carescape Canvas Smart Display Carescape Canvas D19 CARESCAPE RAD E-BIS-01 E-EEGX E-PiCCO-00 E-musb PiCCO Continuous Cardiac Output Cable PiCCO Injectate Sensor Cable N-EEGX
Model Identifier(s)
5876727 5897060 5897061 CARESCAPE RAD E-BIS-01 E-EEGX E-PiCCO-00 E-musb M1154585 M1182448 N-EEGX
About this record

Access comprehensive regulatory information for GE Carescape Canvas Patient Monitors in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508738 and owned by GE Healthcare Finland Oy. The device was registered on December 08, 2023.

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.

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