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GE Hemodynamic Module - HSA Registration DE0007842

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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CLASS C
DE0007842
GE Hemodynamic Module
HSA Registration Number: DE0007842
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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.

Device 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 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