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GE MAC 1600 ECG Analysis System - HSA Registration DE0008937

Access comprehensive regulatory information for GE MAC 1600 ECG Analysis 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 DE0008937 and owned by GE Medical Systems Information Technologies. The device was registered on March 22, 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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CLASS B
DE0008937
GE MAC 1600 ECG Analysis System
HSA Registration Number: DE0008937
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Product Description

The MAC1600 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The MAC1600 is used under the direct supervision of a licensed healthcare practitioner. The MAC 1600 is not designed to provide alarms for arrhythmia detection. The device is not suitable for intra cardiac application. It is not intended for use as a vital signs physiological monitor or for use during patient transport.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDB00112
HS Code
90181100
Registration Information
Registration Number
DE0008937
Registration Date
March 22, 2012
Change Notification Approval Date
February 11, 2014
Retention Due Date
March 21, 2026
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 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
Modem cable, 3.5M Modem cable, 1M Red Grid, Blank Data Area, 8.5" x 11" CAM 14 Leadwire Set, Dedicated Banana, AHA GE Premium Thermal-Sensitive Chart Paper, Full Page Red Grid, A4 Value ECG Cable/Leadwires, 10-L, IEC Reusable Limb Clamp, IEC Reusable Bulb Electrode Value ECG Cable/Leadwires, 10-L, AHA Reusable Limb Clamps, AHA MAC 1600 Resting ECG Analysis System MAC 1600 Resting ECG Analysis System Modular MAC Trolley Kit Slimline MAC1600 Trolley Kit Electrode Adapter, Sure-Lock Electrode Cream Suction Bulb Electrode, Thorax Electrode Electrode Contact Spray, 200ml bottle Electrode Contact Spray, 200ml bottle, 10/box Electrode Contact Spray, 2 L Connection cable to CardioSys Connection cable for TMX425 Connection cable for eBike Connection cable for T2000 / T2100 ECG Cable, 14-L, IEC ECG Cable, Multi-Link, 10-L, IEC ECG Cable, Multi-Link, MAC 500/1200, 10-L, AHA GE Contrast Thermal-Sensitive Chart Paper, Full Page Red Grid, A4 GE Contrast Thermal-Sensitive Chart Paper, Full Page Red Grid 8.5 in x 11 in GE Archivist Thermal-Sensitive Chart Paper, Full Page Red Grid, A4 SET LEADWIRE 4MM, IEC SET LEADWIRE 4MM W/ RES ECG Leadwire Set, Banana, IEC ECG Leadwire Set, Banana, AHA BabyMAC Electrodes CAM 14 ECG Leadwire Set CAM 14 ECG Connector Set, Banana, AHA CAM 14 ECG Connector Set, Banana, IEC SilverTRACE Ag/AgCl Electrodes Premium Paper, Red Grid with Blank Interpretation Area Electrode Adapter Set Silver Mactrode Plus Resting ECG Electrodes
Model Identifier(s)
2008683-001 2008683-002 2009828-061 2016032-001 2020314-001 2029890-001 2029891-001 2029892-001 2029893-001 2029894-001 2035940-001 2038338-001 2055479-001 2055853-001 2056813-010 21708318 21714401 21730701 21730702 21730705 22336203 22336802 22338002 22339003 22340305 22341808 22341809 22616605 22616606 22616611 38401765 38401766 38401816 38401817 402207-210 420101-002 900178-001 900178-101 900703-205 9402-061 9490-210 9623-003P