Medical Device Division · registration 200072Active

GE

Name: GE — Medical Device Division 200072
Creator: GE Medical Systems (China) Co., Ltd.
Keywords: GE, GE, 200072, Scanning Systems, Ultrasonic, General-Purpose, Medical Device Division

Hong KongScanning Systems, Ultrasonic, General-PurposeClass IIGE Medical Systems (China) Co., Ltd.

Verified

Official record identity

MDACS listing number: 200072
Model name: Versana Premier (H48992CA, H48992CB, H48992CH, H48992CJ), Versana Premier Lotus (H48992CC, H48992CD), L6-12-RS Linear Array probe (H48062AC), L4-20t-RS (H48062AJ), E8C-RS probe (H40402LN), E8Cs-RS (H48062AF), E7C8L-RS (H48062AL), M R3 DICOM (H48992CW), M R3 Follow up tool (H48992CY), M R3 LOGIQ VIEW (H48992CZ), M R3 Easy/Adv 3D (H48002DA), M R3 B-flow/color (H48002DB), M R3 Contrast (H48002DC), M R3 4D software (H48002DE), M R3 VOCAL (H48002DF), M R3 Auto IMT (H48002DG), M R3 TVI (H48002DH), M R3 AMM (H48002DJ), M R3 Stress Echo (H48002DK), M R3 Auto EF (H48002DL), M R3 CWD (H48002DM), M R3 Needle rec (H48002DN), M R3 Elastography (H48002DP), M R3 Breast Care (H48002DQ), M R3 Thyroid prod (H48002DR), M R3 Easy Style SW option (H48002DS), M R3 Whizz Label SW option (H48002DT), M R3 V-live 2.0 (H48002DW), M R3 Whizz Follicle (H48002DZ), M R3 Whizz RenderLive (H48012DA), M R3 Imaging Insights (H48012DB), M R3 Strain (H48012DC), M R3 Strain rate (H48012DD), M R3 Intensity Ratio (H48012DE), M R3 6Tc probe SW option (H48032DF), M R3 Li-Rads SW option (H48032DG), M R3 Probe Check (H48072DJ), M R3 L4-20t probe SW option (H48072DL), M R3 Software eDelivery (H48072DTED)
Registration date: May 15, 2025
Expiry date: May 04, 2030
Source update date: August 21, 2025
Status: Active

Classification

Risk class: Class II
Published category: Scanning Systems, Ultrasonic, General-Purpose

Published parties

Registrant / registration holder: GE Medical Systems Hong Kong Limited
Manufacturer: GE Medical Systems (China) Co., Ltd.

Official description

Scanning Systems, Ultrasonic, General-Purpose

Additional source fields

AMD nomenclature code: 15976
Local responsible person phone: 21006300
Published manufacturer address: No. 19, Changjiang Road, Wuxi National Hi-Tech Dev. Zone, 214028 Jiangsu, China
Revision number: b

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.