Singapore HSA registration DE0007842
GE Hemodynamic Module
Singapore·CLASS C·GE Healthcare Finland Oy·Registered November 09, 2011Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90181900
Registration information
- Registration Number
- DE0007842
- Registration Date
- November 09, 2011
- Retention Due Date
- November 08, 2025
Product description
The Hemodynamics Modules are indicated for the monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG including ST-segment and arrhythmia, Impedence respiration, NIBP, temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure. Impedence respiration measurement is indicated for patients aged 3 and up. The NIBP measurement is indicated for patients who weigh 5kg (11lb.) and up. The device is indicated for use by qualified medical personnel only.
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 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model information
- Model Name(s)
- E-P E-PP E-PRESTN E-PRETN E-PT E-RESTN
- Model Identifier(s)
- E-P-00-EN E-PP-00-EN E-PRESTN-00-EN E-PRETN-00-EN E-PT-00-EN E-RESTN-00-EN
About this record
Access comprehensive regulatory information for GE Hemodynamic Module in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007842 and owned by GE Healthcare Finland Oy. The device was registered on November 09, 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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