Singapore HSA registration DE0016596
GE Healthcare CARESCAPE Monitor B450
Singapore·CLASS C·GE Healthcare Finland Oy·Registered November 28, 2014Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0016596
- Registration Date
- November 28, 2014
- Change Notification Approval Date
- August 07, 2024
- Retention Due Date
- November 27, 2025
Product description
The device is a multi-parameter patient monitor intended for use in multiple areas & intrahospital transport within a professional healthcare facility. It is indicated for monitoring of: ● hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis & measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation (only for B450 version 3.2), total hemoglobin concentration (only for B450 version 3.2), cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, central venous oxygen saturation, & Surgical Pleth Index), ● respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, and gas exchange), and ● neurophysiological status (including electroencephalography, Entropy, Bispectral Index, & neuromuscular transmission).
Product Owner
- Short Name
- GE Healthcare Finland Oy
- Address
- Kuortaneenkatu 2, FI-00510 Helsinki, FINLAND
Registrant
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
- Model Name(s)
- Bx50 ESP V2 UPGRADE ENGLISH INTL Bx50 ESP V2 UPGRADE ENGLISH INTL CARESCAPE MONITOR B450 E-EEGX N-EEGX CARESCAPE B450 CARESCAPE RAD Gas Sampling Line, disposable, PVC/PE, 2m/7ft Gas Sampling Line, disposable, PVC/PE, 3m/10ft Gas Sampling Line, disposable, PVC/PE, 6m/20ft E-musb CARESCAPE B450
- Model Identifier(s)
- 2068086-251 2068086-451 2068491-001 2080993-004 2080994-004 2095800-001 2096726-001 2097307-001 2097307-002 2097307-003 5513682 5805686
About this record
Access comprehensive regulatory information for GE Healthcare CARESCAPE Monitor B450 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016596 and owned by GE Healthcare Finland Oy. The device was registered on November 28, 2014.
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