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GE MAC™ 2000 ECG Analysis system - HSA Registration DE0017217

Access comprehensive regulatory information for GE MAC™ 2000 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 DE0017217 and owned by GE Medical Systems Information Technologies. The device was registered on June 12, 2015.

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
DE0017217
GE MAC™ 2000 ECG Analysis system
HSA Registration Number: DE0017217
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Product Description

The MAC™ 2000 ECG Analysis system is a portable ECG acquisition, analysis and recording system that is intended for use by trained operators in a hospital or medical professional’s facility environment , as well as used in clinics , physician offices, outreach centers , or wherever ECG testing is performed

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00104
HS Code
90181100
Registration Information
Registration Number
DE0017217
Registration Date
June 12, 2015
Retention Due Date
June 11, 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)
Value ECG cable/leadwires Value Reusable Limb Clamps Value Reusable Bulb electrodes Value ECG cable/leadwires Value Reusable Limb Clamps Electrode Gel 250 ml MAC 2000 MAC 2000 RR Analysis Value Reusable Bulb electrodes Spray Contact Electrode 200ML ECG cable ECG cable, multi link ECG cable, multi link ECG leadwire set ECG leadwire set ECG leadwire set ECG leadwire set ECG leadwire set Silver Mactrode Resting ECG Electrode
Model Identifier(s)
2029890-001 2029891-001 2029892-001 2029893-001 2029894-001 2034731-002 2056333-001 2063587-106 21714401 21730701 22340305 22341808 22341809 38401765 38401766 38401816 38401817 420101-002 9623-810P