Pure Global AI
Medical Device Division · registration 220395Active

GE

Hong KongElectrocardiographs, Multichannel, InterpretiveClass IIGE Medical Systems Information Technologies, Inc.
Official record identity
MDACS listing number
220395
Model name
MAC 5 A4, MAC 5 A5, MAC 5 Lite
Registration date
November 29, 2022
Expiry date
November 29, 2027
Source update date
July 10, 2023
Status
Active
Official value: Valid
Classification
Risk class
Class II
Official value: II
Published category
Electrocardiographs, Multichannel, Interpretive
Published parties
Registrant / registration holder
GE Medical Systems Hong Kong Limited
Official description

Electrocardiographs, Multichannel, Interpretive

Additional source fields
AMD nomenclature code
16231
Local responsible person phone
21006300
Published manufacturer address
9900 Innovation Drive, Wauwatosa, WI, 53226, USA
About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.