Singapore HSA registration DE0008938
GE MAC 800 Resting ECG analysis system
Singapore·CLASS B·GE Medical Systems (China) Co., Ltd.·Registered March 22, 2012Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0008938
- Registration Date
- March 22, 2012
- Change Notification Approval Date
- August 05, 2016
- Retention Due Date
- March 21, 2026
Product description
The MAC 800 Resting ECG Analysis System is a portable ECG acquisition, analysis and recording system intended to: acquire, analyze, display, and record information from adult and pediatric populations; be used under the direct supervision of a licensed health care practitioner;be used by trained operators in a hospital or medical professional’s facility environment, as well as used in clinics, physician offices, outreach centers;offer two basic modes of operation: (1) resting ECG mode and (2) arrhythmia mode; print 3- and 6 leads of ECG; be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis, provide for the optional transmission and reception of ECG data to and from a central ECG cardiovascular information system.
Product Owner
- Short Name
- GE Medical Systems
- Address
- No.19, Chal1Jiiang Road,, WuXNational Hi-Tech Development, Zone, Jiangsu, 214028, CHINA
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)
- MAC 1100/1200 NEHB KIT LEADWIRE MAC1200 AHA LEADWIRE MAC3500 IEC Value 10LD Patient Cable/Ldwr, IEC Clamp Limb IEC Value 4/SET Boxed W/LBL Reusable Bulb Electr 6/SET Boxed W/LBL Value 10ld cable AHA Clamp Limb AHA Value 4/SET Boxed W/LBL Z-FOLD PAPER-110MM W 10 PACK/BOX MAC800 MAC 800 Resting ECG Analysis System MAC 800 Resting ECG Analysis System Electrode Application System KISS 10 Lead with pump CREAM ELECTRODE 250ML/TUBE CABLE TRUNK 14-LEAD MAC11/1200 2.5M IEC Patient trunk cable, 10-lead IEC Patient trunk cable, 10-lead AHA SET LEADWIRE 4MM 10/SET IEC SET LEADWIRE 4MM W/ RES 2/SET IEC 0.7M PWR SPLY CRD RA BRITSH 10A 250V 2.5M FSD KIT MLINK LEADWIRE SET OF 10 KIT ADAPTER 10 SET AHA BANANA KIT ADAPTER 10 SET BANANA IEC CLIP UNIVERSAL GE 10/PKG SILVER MACTRODE PLUS 1000 / CASE
- Model Identifier(s)
- 2005836-006 2014041-001 2014041-002 2029890-001 2029891-001 2029892-001 2029893-001 2029894-001 2036970-001 2061354-001 2065552-001 21612413 21708318 22340305 22341808 22341809 38401765 38401766 401855-102 420101-002 900178-001 900178-101 9490-210 9623-003P
About this record
Access comprehensive regulatory information for GE MAC 800 Resting 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 DE0008938 and owned by GE Medical Systems (China) Co., Ltd.. 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B