MUSE cardiology Information System - HSA Registration DE0009860
Access comprehensive regulatory information for MUSE cardiology Information System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0009860 and owned by GE Medical Systems Information Technologies. The device was registered on August 31, 2012.
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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HSA Official Data
CLASS B
DE0009860
MUSE cardiology Information System
HSA Registration Number: DE0009860
Product Description
The MUSE Cardiology Information System is intended to store, access and manage cardiology information on adult pediatric patients.
Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00112
HS Code
90181100
Registration Information
Registration Number
DE0009860
Registration Date
August 31, 2012
Change Notification Approval Date
February 26, 2016
Retention Due Date
August 30, 2025
Product Owner
Short Name
GE Medical Systems
Address
8200 West Tower Avenue Milwaukee, WI 53223, UNITED STATES
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)
CASE to MUSE kit
MUSE EveryWare
MUSE EveryWare Upgrade
Mobile Link Module
Network module add
Network Transmission Module
ECG Interval Editor
ECG Serial Comparison (Option Activator) Upgrade
MUSE V8 Server Software
e MUSE V8 SW
e MUSE V8 Software Upgrade to MUSE v8
Server Upgrade Muse App (from V5 to V8)
Server Upgrade Muse App (from V7 to V8)
Server Upgrade Muse App (from V7.0 or V7.0.1 to V8)
Stress Module (Option Activator)
Holter Module (Option Activator)
ECG Serial Comparison (Option Activator)
Enhanced ECG Editor (Option Activator)
MUSE – Monitoring Gateway
3rd Party XML Import Interface (Option Activator)
3rd Party XML Export Interface (Option Activator)
ECG Interval Editor ENG (Option Activator & English manuals)
ECG Reanalysis (Option Activator)
FDA XML Export Interface (Option Activator)
ECG Research Package App CD
MUSE Web Connectivity to GE Devices (Option Activator)
Stress Module (Option Activator) Upgrade
Holter Module (Option Activator) Upgrade
Enhanced ECG Editor (Option Activator) Upgrade
MUSE Web Connectivity to GE Devices (Option Activator) Upgrade
ECG Interval Editor ENG (Option Activator & English manuals) Upgrade
MUSE – Monitoring Gateway Upgrade
3rd Party XML Import Interface (Option Activator) Upgrade
3rd Party XML Export Interface (Option Activator) Upgrade
FDA XML Export Interface (Option Activator) Upgrade
MUSE Application v8.0.0
ECG Research Package App CD Upgrade
HL7 Production Interface
ECG/Stress/Holter Text Results Module (Option Activator)
Waveform Image Results Module (Option Activator)
HL7 Production Interface Upgrade v5
ECG/Stress/Holter Text Results Module (Option Activator) Upgrade v5
Waveform Image Results Module (Option Activator) Upgrade v7 and v8
ECG/Stress/Holter Text Results Module (Option Activator) Upgrade v7 and v8
Waveform Image Results Module (Option Activator) Upgrade v5
HL7 Production Interface Upgrade v7 and v8
CV Web 3.0
MUSE API3
MUSE v9 Software
Standard ECG Module
Serial Comparison Module
Graded Exercise Testing Module
Ambulatory Holter Monitoring Module
Physio-Control data interface
21 CFR Part 11
XML Transaction export
Enhanced ECG Editing Module
Information Exchange interface
Getemed 12SL interface
Model Identifier(s)
2005995-001
2017249-001
2017249-002
2038375-001
2038375-002
2038375-003
2038891-001
205059-149
2054059-046
2054059-048
2054059-049
2054059-052
2054059-053
2054059-054
2054059-063
2054059-064
2054059-065
2054059-066
2054059-068
2054059-069
2054059-070
2054059-072
2054059-073
2054059-074
2054059-075
2054059-092
2054059-147
2054059-148
2054059-150
2054059-153
2054059-156
2054059-157
2054059-158
2054059-159
2054059-160
2054059-189
2054059-343
2054061-016
2054061-020
2054061-021
2054061-044
2054061-048
2054061-052
2054061-146
2054061-150
2054061-155
2060909-007
2060909-013
2091101-001
417516-001
417516-002
417516-004
417516-010
417516-025
417516-026
417516-028
417516-029
417516-035
417516-037