Singapore HSA registration DE0007210
GE Healthcare CARESCAPE Monitor B650
Singapore·CLASS C·GE Healthcare Finland Oy·Registered July 05, 2011Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0007210
- Registration Date
- July 05, 2011
- Change Notification Approval Date
- August 07, 2024
- Retention Due Date
- July 04, 2025
Product description
Intended for use on adult, pediatric,& neonatal patients. One patient at a time. For monitoring of: • hemodynamic (incl. ECG, ST segment, arrhythmia detection, ECG diagnostic analysis & measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution & 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, gas exchange), • neurophysiological status (incl. electroencephalography, Entropy, Bispectral Index, and neuromuscular transmission). Intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
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 Bx50 ESP V2 UPGRADE ENGLISH INTL CARESCAPE Monitor B650 E-EEGX N-EEGX Carescape B650 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 B650 PiCCO Continuous Cardiac Output Cable, 4.1m PiCCO Injectate Sensor Cable, 0.9m Remote-ON cable for Aisys and Avance E-PiCCO-00 Upgrade Program for Solar 8000 to B650 Upgrade Program for Anesthesia Monitor (AM) to B650 Upgrade Program for Critical Care Monitor (CCM) to B650
- Model Identifier(s)
- 2068086-151 2068086-251 2068086-451 2068487-001 2080993-004 2080994-004 2095801-001 2096726-001 2097307-001 2097307-002 2097307-003 5513682 5805688 M1154585 M1182448 M1187043 M1187062 M1197442 M1197443 M1197444
About this record
Access comprehensive regulatory information for GE Healthcare CARESCAPE Monitor B650 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007210 and owned by GE Healthcare Finland Oy. The device was registered on July 05, 2011.
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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