Medical Device Division · registration 230431Active

GE

Name: GE — Medical Device Division 230431
Creator: GE Medical Systems Information Technologies, Inc.
Keywords: GE, GE, 230431, Monitoring Systems, Physiologic, Acute Care, Medical Device Division

Hong KongMonitoring Systems, Physiologic, Acute CareClass IIIGE Medical Systems Information Technologies, Inc.

Verified

Official record identity

MDACS listing number: 230431
Model name: CARESCAPE ONE MBZ323 (2087075-300), CARESCAPE DOCK F0 (2062475-001), CARESCAPE ECG MKE101 (2099884-001), CARESCAPE INVASIVE PRESSURE MKP101 (2099660-001), CARESCAPE TEMPERATURE MKT101 (2099661-001), CARESCAPE SPO2 MKS101 - TRUSIGNAL 1,8M (2099662-001), CARESCAPE SPO2 MKS201 - TRUSIGNAL 3,0M (2099662-002)
Registration date: January 23, 2026
Expiry date: November 22, 2028
Source update date: January 26, 2026
Status: Active

Classification

Risk class: Class III
Published category: Monitoring Systems, Physiologic, Acute Care

Published parties

Registrant / registration holder: GE Medical Systems Hong Kong Limited
Manufacturer: GE Medical Systems Information Technologies, Inc.

Official description

Monitoring Systems, Physiologic, Acute Care

Additional source fields

AMD nomenclature code: 12647
Local responsible person phone: 21006300
Published manufacturer address: 3114 N Grandview Blvd, Waukesha, WI 53188 USA
Revision number: a

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.